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ISRCTN
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ISRCTN31118803
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ClinicalTrials.gov identifier
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Public title
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The Glucose Insulin in Stroke Trial (GIST)
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Scientific title
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Acronym
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GIST UK
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Serial number at source
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RRCC37R R/1805/7005
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Study hypothesis
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Objectives:
To determine by means of a multi-centre randomised controlled clinical trial whether outcome from acute stroke can be favourably influenced by glucose/potassium/insulin induced and maintained euglycaemia.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Multi-centre randomised controlled trial with blinded outcome assessments
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular diseases: Cerebrovascular disease
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Participants - inclusion criteria
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All acute stroke patients (less than 24 hours onset) with cerebral infarction (CI) or primary intracerebral haemorrhage (PICH) and admission plasma glucose greater than 6.1 and less than 17 mMol/l.
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Participants - exclusion criteria
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1. Subarachnoid haemorrhage
2. Renal failure (urea 320 mMol/l or creatinine 3200 mMol/l)
3. Anaemia (Hb less than 9.0 g/dl)
4. Coma
5. Isolated posterior circulation syndromes with no physical disability
6. Pure language disorders
7. Established history of insulin dependent diabetes mellitus
8. Previous disabling stroke (Modified Rankin score 3)
9. Established diagnosis of dementia or abbreviated mental test score less than 7/10
10. Symptomatic cardiac failure - New York Heart Association (NYHA) Grade 3 or 4
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Anticipated start date
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01/09/2002
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Anticipated end date
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30/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2500
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Interventions
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1. Treatment with intravenous 10% glucose solution, 20 mmol KCL and Actrapid insulin (initial insulin 16 units/500ml) at 100 ml per hour.
2. Control treatment with intravenous N saline at 100 ml per hour. Treatment is continued for 24 hours with the objective in the treatment group to maintain blood glucose between 4-7 mmol/L.
Results:
Target recruitment 2,500 patients to detect a minimum 6% difference in mortality at 5% level, power 80%.
Conclusion:
This is the first ever clinical trial of glucose/potassium/insulin induced and maintained euglycaemia following stroke the results of which will be available in late 2006.
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Primary outcome measure(s)
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All cause mortality at 12 weeks.
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Secondary outcome measure(s)
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Proportion of patients with a poor outcome (modified Rankin score 4 - 6) at 12 weeks between treatment groups.
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Sources of funding
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NHS Executive Northern and Yorkshire (UK)
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Trial website
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Publications
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Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/12615981
2. http://www.ncbi.nlm.nih.gov/pubmed/14671236
3. http://www.ncbi.nlm.nih.gov/pubmed/14695867
4. http://www.ncbi.nlm.nih.gov/pubmed/17434094
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Contact name
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Prof
Christopher
Gray
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Address
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Sunderland Royal Hospital
Department of Medicine for the Elderly
Kayll Road
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City/town
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Sunderland
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Zip/Postcode
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SR4 7TP
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Country
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United Kingdom
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Tel
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+44 (0)191 565 6256 ext 41245
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Fax
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+44 (0)191 569 9767
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Email
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chris.gray@chs.northy.nhs.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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19/02/2008
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Date ISRCTN assigned
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23/01/2004
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