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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01565941
Registration number
NCT01565941
Ethics application status
Date submitted
21/03/2012
Date registered
29/03/2012
Titles & IDs
Public title
Heart And Lung Failure - Pediatric INsulin Titration Trial
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Scientific title
Heart And Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT)
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Secondary ID [1]
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U01HL107681
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Secondary ID [2]
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IRB-P00002310
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Universal Trial Number (UTN)
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Trial acronym
HALF-PINT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Respiratory Failure
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Insulin
Treatment: Drugs - Insulin
Active comparator: Tight Glycemic Control 1 (TGC-1) - Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.
Active comparator: Tight Glycemic Control 2 (TGC-2) - Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.
Treatment: Drugs: Insulin
IV insulin titration to target a blood glucose of 80-110 mg/dL
Treatment: Drugs: Insulin
IV insulin titration to target a blood glucose of 150-180 mg/dL
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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ICU-Free Days
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Assessment method [1]
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28-day hospital mortality-adjusted ICU length of stay.
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Timepoint [1]
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Study day 28
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Secondary outcome [1]
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90-day Hospital Mortality
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Assessment method [1]
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In order to enable direct comparisons between data gathered in HALF-PINT and the prior adult NICE-SUGAR trial, we will collect data on 90-day hospital mortality.
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Timepoint [1]
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90 days after randomization
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Secondary outcome [2]
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28-day Hospital Mortality
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Assessment method [2]
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We will collect data on 28-day hospital mortality.
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Timepoint [2]
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28 days after randomization
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Secondary outcome [3]
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Accumulation of Multiple Organ Dysfunction Syndrome (MODS)
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Assessment method [3]
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Accumulation of MODS during the 28 days following randomization will be measured. MODS is defined as the concurrent dysfunction of two or more organ systems (e.g., acute lung injury and renal failure). The clinical relevance of MODS as a surrogate outcome measure is well recognized in the intensive care community, and there is a clear relationship between the number of dysfunctional organ systems and the risk of death in critically ill children.
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Timepoint [3]
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28 days after randomization
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Secondary outcome [4]
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Ventilator-Free Days
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Assessment method [4]
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Ventilator-free days during the 28 days following randomization encompasses both reduction in the duration of ventilation and improvement in mortality. The end of the subject's duration of ventilation is defined as the date/time of extubation for subjects who are intubated, or the date/time of the discontinuation of mechanical ventilation for subjects with tracheostomy.
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Timepoint [4]
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28 days following randomization
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Secondary outcome [5]
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Developmental Neurobehavioral Outcomes: VABS-II Composite
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Assessment method [5]
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Reliable, reproducible measures of adaptive functioning, behavior and quality of life will be used to determine outcomes at baseline (CBCL, PedsQL) and at one year after ICU discharge (Vineland-II, CBCL, PedsQL). The goal of baseline data collection is to assess pre-ICU health and quality of life. The results of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) are reported. Scores range from 20-160, with higher scores being better.
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Timepoint [5]
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One year after ICU course
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Secondary outcome [6]
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Participants With Device-Related or Non-Device Related Nosocomial Infection
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Assessment method [6]
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We will use Centers for Disease Control's (CDC) most recently published definitions for the following nosocomial infections attributable to the ICU stay: total bloodstream infections including Central Venous Line (CVL)-associated bloodstream infections (BSI), respiratory tract infections including ventilator-associated pneumonias, urinary tract infections, and wound infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit.
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Timepoint [6]
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Up to 48 hours after ICU discharge
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Secondary outcome [7]
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Incidence of Catheter-Associated Bloodstream Infection
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Assessment method [7]
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We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: Central Venous Line (CVL)-associated bloodstream infections (BSI) that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.
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Timepoint [7]
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Up to 48 hours after ICU discharge
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Secondary outcome [8]
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Incidence of Catheter-Associated Urinary Tract Infection
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Assessment method [8]
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We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: urinary tract infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.
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Timepoint [8]
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Up to 48 hours after ICU discharge
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Secondary outcome [9]
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Incidence of Ventilator-Associated Pneumonia
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Assessment method [9]
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We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: respiratory tract infections including ventilator-associated pneumonias that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.
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Timepoint [9]
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Up to 48 hours after ICU discharge
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Secondary outcome [10]
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Incidence of Wound Infection Incidence of Wound Infection
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Assessment method [10]
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We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: wound infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This non-device-related infection will be counted per 1,000 ICU days.
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Timepoint [10]
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Up to 48 hours after ICU discharge
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Secondary outcome [11]
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Participants With Severe Hypoglycemia (<40 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)
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Assessment method [11]
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Hypoglycemia will be tracked and reported according to three ranges: severe (\<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia \<2.5 mmol/L will also be tracked.
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Timepoint [11]
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Participants will be followed for the duration of ICU stay, an expected average of 8 days
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Secondary outcome [12]
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Participants With Severe Hypoglycemia (<40 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)
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Assessment method [12]
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Hypoglycemia will be tracked and reported according to three ranges: severe (\<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia \<2.5 mmol/L will also be tracked.
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Timepoint [12]
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Participants will be followed for the duration of ICU stay, an expected average of 8 days
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Secondary outcome [13]
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Participants With Any Hypoglycemia (<60 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)
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Assessment method [13]
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Hypoglycemia will be tracked and reported according to three ranges: severe (\<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia \<2.5 mmol/L will also be tracked.
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Timepoint [13]
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Participants will be followed for the duration of ICU stay, an expected average of 8 days
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Secondary outcome [14]
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Participants With Any Hypoglycemia (<60 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)
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Assessment method [14]
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Hypoglycemia will be tracked and reported according to three ranges: severe (\<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia \<2.5 mmol/L will also be tracked.
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Timepoint [14]
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Participants will be followed for the duration of ICU stay, an expected average of 8 days
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Secondary outcome [15]
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Participants With Hypokalemia (<2.5 mmol/L)
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Assessment method [15]
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Hypoglycemia will be tracked and reported according to three ranges: severe (\<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia \<2.5 mmol/L will also be tracked.
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Timepoint [15]
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Participants will be followed for the duration of ICU stay, an expected average of 8 days
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Secondary outcome [16]
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Nursing Workload: SWAT (Subjective Workload Assessment Technique) Instrument
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Assessment method [16]
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The workload burden placed upon bedside nurses when managing a patient on TGC will be described. Bedside nurses will be randomly selected to complete an anonymous survey describing their perceptions of workload burden associated with managing a patient during one shift.
Using the SWAT (Subjective Workload Assessment Technique) instrument, perceived workload of Pediatric Intensive Care Nurses caring for HALF-PINT patients in TGC group 1 and TGC group 2 were assessed. The SWAT has been used to study the effect of workload in the fields of nursing, pharmacy and medicine. It measures the following burdens: cognitive (mental effort or concentration required for complexity of task), time (amount of spare time, interruptions, overlapping tasks) and psychological stress associated with work that impacts performance. The SWAT uses a ranking system to weight perceived workload which results in an overall score ranging from 0-100, where higher scores indicate higher perceived workload.
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Timepoint [16]
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One nursing shift caring for patient on TGC, at anytime during the patient's hospital stay through the tenth nursing shift for the patient. Shift determined randomly by the last digit of the study ID number, 0-9 (0=shift 10, 1=shift 1, 2=shift 2, etc.).
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Secondary outcome [17]
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Nursing Workload: NASA-TLX (National Aeronautics and Space Administration - Task Load Index) Instrument
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Assessment method [17]
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The cognitive burden placed upon bedside nurses when managing a patient on TGC will be described. Bedside nurses will be randomly selected to complete an anonymous survey describing their perceptions of workload burden associated with managing a patient on TGC.
Using the NASA-TLX instrument, perceived workload of Pediatric Intensive Care Nurses caring for HALF-PINT patients in TGC group 1 and TGC group 2 were assessed. The instrument uses a ranking system to weight perceived workload which results in an overall sore ranging from 0-100, where higher scores indicate higher perceived workload. It obtains overall perception of workload related to stressful tasks and includes 6 dimensions (cognitive demand, physical demand, time pressure, performance, effort, and frustration.
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Timepoint [17]
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One nursing shift caring for patient on TGC, at anytime during the patient's hospital stay through the tenth nursing shift for the patient. Shift determined randomly by the last digit of the study ID number, 0-9 (0=shift 10, 1=shift 1, 2=shift 2, etc.).
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Secondary outcome [18]
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Insulin Algorithm Performance: Time to the Target Range
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Assessment method [18]
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Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. Ideally, the algorithm will minimize time to glucose target range. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.
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Timepoint [18]
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Until study discharge, up to 28 days following randomization
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Secondary outcome [19]
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Insulin Algorithm Performance: Time in the Target Range
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Assessment method [19]
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Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. Ideally, the algorithm will maximize time spent in the glucose target range. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.
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Timepoint [19]
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Until study discharge, up to 28 days following randomization
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Secondary outcome [20]
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Insulin Algorithm Performance: Time-Weighted Glucose Average
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Assessment method [20]
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Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.
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Timepoint [20]
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Until study discharge, up to 28 days following randomization
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Eligibility
Key inclusion criteria
* Cardiovascular failure and/or respiratory failure:
1. Cardiovascular Failure: Dopamine or dobutamine > 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, phenylephrine, milrinone or vasopressin if used to treat hypotension.
2. Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy.
* Age >= 2 weeks and corrected gestational age >= 42 weeks
* Age < 18 years (has not yet had 18th birthday)
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Minimum age
2
Weeks
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* No longer has cardiovascular or respiratory failure (as defined in inclusion criterion 1), or is expected to be extubated in the next 24 hours
* Expected to remain in ICU < 24 hours
* Previously randomized in HALF-PINT
* Enrolled in a competing clinical trial
* Family/team decision to limit/redirect from aggressive ICU technological support
* Chronic ventilator dependence prior to ICU admission (non-invasive ventilation and ventilation via tracheostomy overnight or during sleep are acceptable)
* Type 1 or 2 diabetes
* Cardiac surgery within prior 2 months or during/planned for this hospitalization (extra-corporeal life support or non-cardiac surgery is acceptable)
* Diffuse skin disease that does not allow securement of a subcutaneous sensor
* Therapeutic plan to remain intubated for >28 days
* Receiving therapeutic cooling with targeted body temperatures <34 degrees Celsius
* Current or planned ketogenic diet
* Ward of the state
* Pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2018
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Sample size
Target
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Accrual to date
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Final
713
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Royal Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3052 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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Connecticut
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United States of America
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Delaware
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United States of America
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Georgia
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United States of America
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Illinois
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Country [7]
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New Hampshire
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United States of America
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New York
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Country [14]
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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Country [18]
0
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United States of America
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Texas
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Country [19]
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United States of America
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State/province [19]
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Utah
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United States of America
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Washington
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Canada
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State/province [21]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
Boston Children's Hospital
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Heart, Lung, and Blood Institute (NHLBI)
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels, is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult critically ill surgical patients but has since come under intense scrutiny due to conflicting results in recent adult trials. One pediatric RCT has been published to date that demonstrated survival benefit but was complicated by an unacceptably high rate of severe hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a multi-center, randomized clinical treatment trial comparing two ranges of glucose control in hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of glucose control fall within the range of "usual care" for critically ill children managed in pediatric intensive care units. The purpose of the study is to determine the comparative effectiveness of tight glycemic control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of 150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU) length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or respiratory failure. This will be accomplished using an explicit insulin titration algorithm and continuous glucose monitoring to safely achieve these glucose targets. Both groups will receive identical standardized intravenous glucose at an age-appropriate rate in order to provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an explicit algorithm combined with continuous glucose monitoring using a protocol that has been safely implemented in 490 critically ill infants and children.
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Trial website
https://clinicaltrials.gov/study/NCT01565941
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Trial related presentations / publications
Agus MS, Hirshberg E, Srinivasan V, Faustino EV, Luckett PM, Curley MA, Alexander J, Asaro LA, Coughlin-Wells K, Duva D, French J, Hasbani N, Sisko MT, Soto-Rivera CL, Steil G, Wypij D, Nadkarni VM. Design and rationale of Heart and Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT): A randomized clinical trial of tight glycemic control in hyperglycemic critically ill children. Contemp Clin Trials. 2017 Feb;53:178-187. doi: 10.1016/j.cct.2016.12.023. Epub 2016 Dec 30. Hirshberg EL, Alexander JL, Asaro LA, Coughlin-Wells K, Steil GM, Spear D, Stone C, Nadkarni VM, Agus MSD; HALF-PINT Study Investigators. Performance of an Electronic Decision Support System as a Therapeutic Intervention During a Multicenter PICU Clinical Trial: Heart and Lung Failure-Pediatric Insulin Titration Trial (HALF-PINT). Chest. 2021 Sep;160(3):919-928. doi: 10.1016/j.chest.2021.04.049. Epub 2021 Apr 29. LaMarra D, French J, Bailey C, Sisko MT, Coughlin-Wells K, Agus MSD, Srinivasan V, Nadkarni VM; Heart And Lung Failure-Pediatric INsulin Titration (HALF-PINT) Study Investigators. A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research. Pediatr Crit Care Med. 2020 Dec;21(12):e1042-e1051. doi: 10.1097/PCC.0000000000002484. Biagas KV, Hinton VJ, Hasbani NR, Luckett PM, Wypij D, Nadkarni VM, Agus MSD; HALF-PINT trial study investigators; PALISI Network. Long-Term Neurobehavioral and Quality of Life Outcomes of Critically Ill Children after Glycemic Control. J Pediatr. 2020 Mar;218:57-63.e5. doi: 10.1016/j.jpeds.2019.10.055. Epub 2020 Jan 3. Srinivasan V, Hasbani NR, Mehta NM, Irving SY, Kandil SB, Allen HC, Typpo KV, Cvijanovich NZ, Faustino EVS, Wypij D, Agus MSD, Nadkarni VM; Heart and Lung Failure-Pediatric Insulin Titration (HALF-PINT) Study Investigators. Early Enteral Nutrition Is Associated With Improved Clinical Outcomes in Critically Ill Children: A Secondary Analysis of Nutrition Support in the Heart and Lung Failure-Pediatric Insulin Titration Trial. Pediatr Crit Care Med. 2020 Mar;21(3):213-221. doi: 10.1097/PCC.0000000000002135. Agus MS, Wypij D, Hirshberg EL, Srinivasan V, Faustino EV, Luckett PM, Alexander JL, Asaro LA, Curley MA, Steil GM, Nadkarni VM; HALF-PINT Study Investigators and the PALISI Network. Tight Glycemic Control in Critically Ill Children. N Engl J Med. 2017 Feb 23;376(8):729-741. doi: 10.1056/NEJMoa1612348. Epub 2017 Jan 24.
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Public notes
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Contacts
Principal investigator
Name
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Michael SD Agus, MD
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Address
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Boston Children's Hospital
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Fax
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Email
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Contact person for public queries
Name
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01565941