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Trial registered on ANZCTR


Registration number
ACTRN12611001261909
Ethics application status
Approved
Date submitted
30/11/2011
Date registered
8/12/2011
Date last updated
8/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stochastic Targeted Glycemic Control in the Intensive Care Unit Pilot Trials
Scientific title
Insulin and Nutrition Dosing Using a Stochastic Targeting Model-Based System for Improved Control of Blood Glucose Levels in Intensive Care Patients
Secondary ID [1] 273485 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress-induced Hyperglycaemia 279275 0
Condition category
Condition code
Metabolic and Endocrine 279541 279541 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
STAR is a system that uses an algorithm and computer model to provide equivalent or tighter control of glucose levels. Target glycemic levels will be chosen by the clinical staff dependent on patient characteristics, the most common target range is 4.4-8.0 mmol/L. The algorithm will determine all insulin doses and enteral nutrition given to achieve that target with safety from hypoglycemia. STAR clinical trials will run until 30 June 2012 and will occur whenever there is an eligible patient in the ICU from whom consent has been obtained.
Intervention code [1] 283803 0
Treatment: Other
Comparator / control treatment
Retrospective data (of blood glucose, insulin and nutrition) from SPRINT (the current tight glycaemic control protocol in use in Christchurch hospital). The data was gathered from August 2005-May 2007.
Control group
Historical

Outcomes
Primary outcome [1] 286041 0
Time in target glycaemic control bands (e.g. 4 to 7 mmol/L)
Timepoint [1] 286041 0
As a percentage of total time on STAR for each patient throughout their time on STAR. Blood glucose (BG) measurements are taken 1-3 hourly.
Primary outcome [2] 286042 0
Numbers of patients who experience hypoglycaemia (BG < 2.2 mmol/L) and numbers or percentage of measurements lower than 4.0 mmol/L.
Timepoint [2] 286042 0
Data taken from each patients time on STAR. Blood glucose (BG) measurements are taken 1-3 hourly.
Secondary outcome [1] 295030 0
Measures of glycaemic variability (standard deviation, variation over time)
Timepoint [1] 295030 0
Blood glucose (BG) measurements are taken 1-3 hourly for each patient.

Eligibility
Key inclusion criteria
1 In-patient in Intensive Care.
2 Blood glucose >8 mmol/L, same as with SPRINT.
3 In-situ arterial line.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Moribund or not expected to survive >72 hours
2 No arterial line present

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients will be in-patients in intensive care and will be identified by investigators according to the entry criteria. The intensive care clinicians will approach the patient or if the patient cannot consent him/herself a family/whanau/representative will be approached. All contact will be made within the Department of Intensive Care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3982 0
New Zealand
State/province [1] 3982 0
Christchurch

Funding & Sponsors
Funding source category [1] 284277 0
University
Name [1] 284277 0
University of Canterbury Dept of Mechanical Engineering
Address [1] 284277 0
Dept of Mechanical Engineering
University of Canterbury
Private Bag 4800
Christchurch
Country [1] 284277 0
New Zealand
Primary sponsor type
Individual
Name
Dr Geoffrey M Shaw
Address
Department of Intensive Care Medicine
Christchurch Hospital
2 Riccarton Avenue
Private Bag 4710, Christchurch
Country
New Zealand
Secondary sponsor category [1] 283228 0
Individual
Name [1] 283228 0
Prof. J. Geoffrey Chase
Address [1] 283228 0
Dept of Mechanical Engineering
University of Canterbury
Private Bag 4800
Christchurch
Country [1] 283228 0
New Zealand
Secondary sponsor category [2] 283229 0
Individual
Name [2] 283229 0
Dr Aaron Le Compte
Address [2] 283229 0
Dept of Mechanical Engineering
University of Canterbury
Private Bag 4800
Christchurch
Country [2] 283229 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286252 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 286252 0
c/- Ministry of Health
Montgomery Watson Building
6 Hazeldean Rd
Christchurch 8023
Ethics committee country [1] 286252 0
New Zealand
Date submitted for ethics approval [1] 286252 0
Approval date [1] 286252 0
07/10/2010
Ethics approval number [1] 286252 0
URA/10/09/069

Summary
Brief summary
Critically ill patients often experience stress-induced hyperglycaemia (high blood sugar levels) and insulin resistance, resulting in increased infection, cardiac events and death. The Christchurch ICU currently controls glucose levels using a system called SPRINT, a paper-based protocol that has provided world leading control and reduced mortality 25-40% in patients who stay 3 days or longer in the ICU. It has also reduced costs by over $1000 per patient treated. However, SPRINT does not allow clinicians to make changes or provide more patient-specific care, when necessary.

STAR is a system that uses an algorithm and computer model to provide equivalent or tighter control of glucose levels with greater clinical flexibility and less nursing effort through reduced need for measurements or/and intervention. It also improves safety from low glucose levels (hypoglycaemia) using a statistical model to provide a guaranteed risk of hypoglycemia of 0.1%. STAR pilot trials will be supervised by medical personnel and run for as long as a patient requires glycemic control during their ICU stay. Target glycemic levels will be chosen by the clinical staff. The algorithm will determine all insulin doses and enteral nutrition given to achieve that target with guaranteed safety from hypoglycemia.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33453 0
Address 33453 0
Country 33453 0
Phone 33453 0
Fax 33453 0
Email 33453 0
Contact person for public queries
Name 16700 0
Dr. Geoffrey M Shaw
Address 16700 0
Department of Intensive Care Medicine
Christchurch Hospital
2 Riccarton Avenue
Private Bag 4710, Christchurch
Country 16700 0
New Zealand
Phone 16700 0
+64 3 364 1077
Fax 16700 0
+64 3 364 0099
Email 16700 0
geoff.shaw@cdhb.govt.nz
Contact person for scientific queries
Name 7628 0
Dr. Geoffrey M Shaw
Address 7628 0
Department of Intensive Care Medicine
Christchurch Hospital
2 Riccarton Avenue
Private Bag 4710, Christchurch
Country 7628 0
New Zealand
Phone 7628 0
+64 3 364 1077
Fax 7628 0
+64 3 364 0099
Email 7628 0
geoff.shaw@cdhb.govt.nz

No data has been provided for results reporting
Summary results
Not applicable