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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02841943
Registration number
NCT02841943
Ethics application status
Date submitted
15/07/2016
Date registered
22/07/2016
Titles & IDs
Public title
Fluid Responsiveness After CArdiac Surgery Study
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Scientific title
Fluid Responsiveness After Cardiac Surgery (FRACAS) Study
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Secondary ID [1]
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LIVICU001
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Universal Trial Number (UTN)
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Trial acronym
FRACAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critically Ill
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Hypovolemia
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Condition category
Condition code
Blood
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Other blood disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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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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Fluid bolus responsiveness
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Assessment method [1]
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Fluid responsiveness will be determined by any increase in cardiac output (continuous outcome) or by a 10-15% increase in cardiac output (dichotomous outcome) following bolus volume expansion
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Timepoint [1]
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Approximately 30 minutes
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Primary outcome [2]
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Volume management responsiveness
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Assessment method [2]
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Responders will be defined as patients with an improvement (change towards normal physiological values) following cumulative volume expansion in any variable(s) used to assess oxygen delivery/consumption balance
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Timepoint [2]
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Approximately 6 hours
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Secondary outcome [1]
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Morbidity
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Assessment method [1]
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Use and extent of measures to support organ function such as mechanical ventilation, mechanical and pharmacological cardiovascular interventions, renal replacement therapy whilst admitted to ICU as well as length of admission to ICU.
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Timepoint [1]
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At ICU discharge, an average of 4 days
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Secondary outcome [2]
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Mortality
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Assessment method [2]
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Vital status censored at discharge from ICU and hospital
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Timepoint [2]
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Up to 3 months
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Eligibility
Key inclusion criteria
* Admitted following elective cardiac surgery
* Adult (>18 years of age)
* Pulmonary artery, central venous and arterial catheters inserted
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Minimum age
18
Years
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Maximum age
No limit
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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
* Emergency Patients (surgery immediately or within 12 hours of admission to hospital)
* Children (< 18 years of age)
* Patients admitted to ICU with ongoing extracorporeal circulatory support
* Patients re-admitted to ICU within same index hospital admission
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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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
1/03/2016
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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
1/12/2016
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Sample size
Target
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Accrual to date
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Final
102
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District - Liverpool
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Recruitment postcode(s) [1]
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1871 - Liverpool
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Funding & Sponsors
Primary sponsor type
Other
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Name
South West Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Study Design: Prospective observational study Study Location: Liverpool Hospital Intensive Care Unit, South Western Sydney Local Health District, Sydney, Australia. Target study size: 100 patients Ethics: Approved by the local Human Research and Ethics Council (HREC) at Liverpool Hospital (LPOOL) as a Low Negligible Risk (LNR) project \[HREC/LNR/14/LPOOL/295, HREC/LNR/15/LPOOL47, HREC/LNR/14/LPOOL/150\] Participants: Post cardiac surgical patients admitted to the Intensive Care Unit between March-October 2016 Aims: 1. to determine the descriptive and predictive value of variables (outlined below) related to oxygen delivery/consumption in regards to the effects of intravascular volume expansion 2. to assess correlations between central and peripheral variables (outlined below) relevant to oxygen delivery/consumption 3. to assess correlations between a set of variables (outline below) and patient centred outcomes in ICU and in hospital Main variables collected: 1. Tissue oxygen saturation by peripheral Near-Infrared Spectroscopy (NIRS) 2. Common carotid arterial Doppler 3. Arterial/mixed venous/central venous blood gas analyses 4. Haemodynamic parameters 5. Organ support measures Data collection time points: 1. ICU admission (within 30 minutes) 2. Before administration of a fluid bolus 3. After administration of a fluid bolus 4. 6 hours after ICU admission 5. Morning of first postoperative day (12-24 hours) Outcome measures: 1. the response to intravascular volume expansion 2. ICU mortality, morbidity and length of stay and hospital mortality and length of stay Data analysis: 1. Clinical data are collected bedside using an electronic case record form 2. Descriptive statistics 3. Paired and unpaired comparative 4. Correlative and predictive statistics
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Trial website
https://clinicaltrials.gov/study/NCT02841943
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Trial related presentations / publications
Gupta K, Sondergaard S, Parkin G, Leaning M, Aneman A. Applying mean systemic filling pressure to assess the response to fluid boluses in cardiac post-surgical patients. Intensive Care Med. 2015 Feb;41(2):265-72. doi: 10.1007/s00134-014-3611-2. Epub 2015 Jan 8. Sondergaard S, Parkin G, Aneman A. Central venous pressure: soon an outcome-associated matter. Curr Opin Anaesthesiol. 2016 Apr;29(2):179-85. doi: 10.1097/ACO.0000000000000305. Rangappa R, Sondergaard S, Aneman A. Improved consistency in interpretation and management of cardiovascular variables by intensive care staff using a computerised decision-support system. Crit Care Resusc. 2014 Mar;16(1):48-53.
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Public notes
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Contacts
Principal investigator
Name
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Anders Aneman, MD, PhD
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Address
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Liverpool Hospital, South Western Sydney Local Health District
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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)?
No
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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 not provided in
https://clinicaltrials.gov/study/NCT02841943