Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000574044
Ethics application status
Not yet submitted
Date submitted
14/07/2010
Date registered
16/07/2010
Date last updated
16/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Proof-of-Concept Study of Insulin Glargine as Basal Insulin Support for Recovering Critically Ill Patients
Scientific title
Proof-of-Concept Study of Insulin Glargine as Basal Insulin Support for patients with stress diabetes in the Intensive Care and the High Dependency Units and Validation of an Insulin Glargine Pharmacokinetics Model
Secondary ID [1] 252221 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress diabetes in critical illness 257743 0
Condition category
Condition code
Metabolic and Endocrine 257917 257917 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recovering critically ill patients who meets the study inclusion criteria will be given insulin glargine once a day. The dose will be determined by a titration algorithm. Blood samples will be taken for assays of plasma insulin and C-peptide 3 times a day for the first two days a patient is receiving glargine. The samples will be taken before glargine injection, 6 hours from time of injection, and 14 hours from time of injection. The patient will continue to receive glargine for blood glucose control unless the dose become less than 10U. When the patient begins to consume meals (as oppose to naso-gastric feed), blood samples will be taken 8 times a day for the first two days. These samples will be taken before glargine injection and breakfast, before lunch, before dinner, 30 mins from start of dinner, 1 hr from start of dinner, 1.5 hrs from start of dinner, 2 hrs from start of dinner, and 4 hrs from start of dinner. Photos will be taken of the meal before and after mealtime to determine nutrition intake.
Intervention code [1] 256806 0
Treatment: Drugs
Intervention code [2] 256807 0
Treatment: Other
Intervention code [3] 256808 0
Other interventions
Comparator / control treatment
standard intensive care blood glucose control protocol without the use of glargine
Control group
Active

Outcomes
Primary outcome [1] 258777 0
Goodness of blood glucose control - median and range of blood glucose levels
Timepoint [1] 258777 0
at termination of study
Primary outcome [2] 258778 0
amount of total insulin administered
Timepoint [2] 258778 0
at termination of study
Primary outcome [3] 258779 0
nursing effort as assessed by blood glucose measurement frequency plus insulin dosing adjustment frequency
Timepoint [3] 258779 0
at termination of study
Secondary outcome [1] 264838 0
Glargine pharmacokinetics mathematical model validation assessed by data fitting accuracy
Timepoint [1] 264838 0
at termination of study
Secondary outcome [2] 264839 0
Mathematical meal model validation assessed by data fitting accuracy
Timepoint [2] 264839 0
at termination of study
Secondary outcome [3] 264840 0
Mathematical endogenous insulin production model validation assessed by data fitting accuracy
Timepoint [3] 264840 0
at termination of study

Eligibility
Key inclusion criteria
- Stable hourly insulin requirement, equal to or less than 3U of intravenous insulin per hour, for at least 12 hours.
- Stable naso-gastric feed rate, equal to or greater than 60% of the calculated goal feed. (Goal feed is calculated using individual patient’s age, gender and frame size.)
- No acute renal failure (creatinine < 250 micromol/L)
- Less than 1000ml of fluid given as intravenous boluses in the past 24 hours, indicating stable interstitial volume.
- Resolving multiple organ failure (Sequential Organ Failure Assessment Score SOFA<=6).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
insulin dependent diabetes, absence of an arterial line, not expected to survive for more than 3 days at the time of screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2764 0
New Zealand
State/province [1] 2764 0

Funding & Sponsors
Funding source category [1] 257284 0
Government body
Name [1] 257284 0
Canterbury Medical Research Foundation
Country [1] 257284 0
New Zealand
Primary sponsor type
Government body
Name
Canterbury District Health Board/Christchurch Hospital
Address
Riccarton Avenue
Private Bag 4710
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 256529 0
University
Name [1] 256529 0
University of Canterbury
Address [1] 256529 0
Private Bag 4800
Christchurch 8140
Country [1] 256529 0
New Zealand
Secondary sponsor category [2] 256530 0
University
Name [2] 256530 0
University of Otago Christchurch
Address [2] 256530 0
2 Riccarton Avenue
PO Box 4345
Christchurch 8140
Country [2] 256530 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259309 0
Upper South Regional Ethics Committee
Ethics committee address [1] 259309 0
Ethics committee country [1] 259309 0
New Zealand
Date submitted for ethics approval [1] 259309 0
19/07/2010
Approval date [1] 259309 0
Ethics approval number [1] 259309 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31395 0
Address 31395 0
Country 31395 0
Phone 31395 0
Fax 31395 0
Email 31395 0
Contact person for public queries
Name 14642 0
Dr. Geoffrey M Shaw
Address 14642 0
Intensive Care Unit
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch 8140
Country 14642 0
New Zealand
Phone 14642 0
+64 3 3640640 x88581
Fax 14642 0
Email 14642 0
[email protected]
Contact person for scientific queries
Name 5570 0
Prof. J Geoffrey Chase
Address 5570 0
Department of Mechanical Engineering
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 5570 0
New Zealand
Phone 5570 0
+64 3 3642987 x7224
Fax 5570 0
Email 5570 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.