The Glucose Insulin in Stroke Trial (GIST)
| ISRCTN | ISRCTN31118803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31118803 |
| Secondary identifying numbers | RRCC37R R/1805/7005 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christopher Gray
Scientific
Scientific
Sunderland Royal Hospital
Department of Medicine for the Elderly
Kayll Road
Sunderland
SR4 7TP
United Kingdom
| Phone | +44 (0)191 565 6256 ext 41245 |
|---|---|
| chris.gray@chs.northy.nhs.uk |
Study information
| Study design | Multi-centre randomised controlled trial with blinded outcome assessments |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The Glucose Insulin in Stroke Trial (GIST) |
| Study acronym | GIST UK |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: Cerebrovascular disease |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | All-cause mortality at 12 weeks. |
| Secondary outcome measures | Proportion of patients with a poor outcome (modified Rankin score 4 - 6) at 12 weeks between treatment groups. |
| Overall study start date | 01/09/2002 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 2500 |
| Key inclusion criteria | 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. |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sunderland Royal Hospital
Sunderland
SR4 7TP
United Kingdom
SR4 7TP
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Hospital/treatment centre
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 01/03/2003 | Yes | No | ||
| Other publications | 01/01/2004 | Yes | No | ||
| Other publications | 01/01/2004 | Yes | No | ||
| Results article | 01/05/2007 | Yes | No |
Editorial Notes
01/09/2022: Internal review.
