Glucose-insulin-potassium infusion in patients treated with primary percutaneous coronary intervention for acute myocardial infarction
| ISRCTN | ISRCTN56720616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56720616 |
| Secondary identifying numbers | 99.028 |
- Submission date
- 17/05/2005
- Registration date
- 20/05/2005
- Last edited
- 15/02/2008
- 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 Felix Zijlstra
Scientific
Scientific
Hanzeplein 1
Groningen
30.001
Netherlands
| Phone | +31 (0)503612355 |
|---|---|
| f.zijlstra@thorax.umcg.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | Glucose-Insulin-Potassium Study (GIPS) |
| Study objectives | In this study we considered the question of whether adjunction of glucose-insulin-potassium (GIK) infusion to primary coronary transluminal angioplasty (PTCA) is effective in patients with an acute myocardial infarction (MI). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | ST elevation myocardial infarction (mi) |
| Intervention | After admission, patients were randomly assigned to either glucose-insulin-potassium (GIK) infusion or no infusion. In patients randomized to GIK, a continuous infusion of 80 mmol potassium chloride in 500 ml 20% glucose with a rate of 3 ml/kg body weight/hour over an 8- to 12-hour period in a peripheral venous line was given, as soon as possible. A continuous infusion of short-acting insulin (50 U Actrapid) in 50 ml 0.9% sodiumchloride was started. Baseline insulin-infusion dose and hourly adjustments of the insulin dose were based on an algorithm to obtain blood-glucose levels between 7.0 and 11.0 mmol/l. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | glucose-insulin-potassium |
| Primary outcome measure | 30-day mortality |
| Secondary outcome measures | Recurrent infarction, repeat coronary angioplasty, and the composite incidence of death, recurrent infarction, or repeat coronary angioplasty. |
| Overall study start date | 01/04/1998 |
| Completion date | 30/09/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 940 |
| Key inclusion criteria | All consecutive patients with symptoms consistent with acute MI of >30 min duration, presenting within 24 hours after the onset of symptoms and with an ST-segment elevation of more than 1 mm (0.1 mV) in two or more contiguous leads on the electrocardiogram, or new onset left bundle branch block, were evaluated for inclusion in this single-center study. Patients presented at our center and patients referred for treatment of high-risk myocardial infarction (MI) from nine referring hospitals without angioplasty facilities were included. |
| Key exclusion criteria | Patients were excluded when pre-treated with thrombolysis or when an illness associated with a marked restricted life expectancy was present. |
| Date of first enrolment | 01/04/1998 |
| Date of final enrolment | 30/09/2001 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hanzeplein 1
Groningen
30.001
Netherlands
30.001
Netherlands
Sponsor information
Netherlands Heart Foundation (Netherlands)
Charity
Charity
Bordewijklaan 3
The Hague
300
Netherlands
| Phone | +31 (0)703155555 |
|---|---|
| info@hartstichting.nl | |
| Website | http://www.hartstichting.nl/go/ |
"ROR" |
https://ror.org/05nxhgm70 |
Funders
Funder type
Charity
Netherlands Heart Foundation (99.028)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/06/2005 | Yes | No |
