Metabolic control with Glucose-Insulin-Potassium infusion in acute myocardial infarction
| ISRCTN | ISRCTN08189331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08189331 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 17/10/2007
- 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
Dr J Klijn
Scientific
Scientific
Diagram B.V. Zwolle
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
| Phone | +31 (0)38 426 2997 |
|---|---|
| j.klijn@diagram-zwolle.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | GIPS II |
| Study objectives | Treatment with Glucose-Insulin-Potassium (GIK) infusion during the acute phase of myocardial infarction has been proposed as therapeutic intervention for protection of the ischaemic myocardium. Current evidence suggests an effect in patients with acute myocardial infarction without signs of heart failure at admission treated with reperfusion therapy (i.e. primary coronary angioplasty). There is also evidence for the treatment with insulin-glucose infusion in combination with strict metabolic control for at least three months thereafter for patients with type two diabetes mellitus (i.e. a history of diabetes mellitus, previously treated with oral hypoglycaemic agents or blood glucose level at admission greater than or equal to 11.1 mmol/l) and acute myocardial infarction. Recently, it has been shown that obtaining and maintaining normoglycaemia (i.e. plasma-glucose concentrations of 4.4 and 6.1 mmol/l) in patients admitted to a Surgical Intensive Care Unit will lead to a marked reduction in morbidity and mortality. This study will address what the effects will be of metabolic intervention with or without the infusion of GIK on 30-day and one-year mortality in patients eligible for reperfusion therapy (i.e. primary coronary angioplasty or thrombolysis). |
| Ethics approval(s) | Approval received from the local ethics committee (Medisch Ethische Toetsings Commissie) on the 2nd May 2003 (ref: 02.1280). |
| Health condition(s) or problem(s) studied | Acute myocardial infarction |
| Intervention | An infusion of 80 mmol potassium chloride in 500 ml 20% glucose with a rate of 2 ml/kilogram body weight/hour over an 12 hour period in a peripheral venous line. The infusion is started as soon as possible after admission to the hospital after determination of blood-glucose level in combination with reperfusion therapy. A continuous infusion of short-acting insulin (50 units Actrapid HM [Novo Nordisk, Copenhagen, Denmark] in 49.5 ml of 0.9 percent sodium chloride) with the use of a perfusor-pump will also be started. Blood-glucose levels will be measured hourly. Baseline insulin infusion dose and adjustments of insulin dose will be based on a nomogram to obtain and maintain blood-glucose levels of 6.0 to 10.0 mmol/l. The insulin infusion will be stopped one hour prior to the discontinuation of the glucose-potassium infusion. After the Glucose-Potassium (GK) infusion is stopped insulin may be continued based on glucose measurements according to conventional care or until the infusion rate is less than 1 IU/hour. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glucose-Insulin-Potassium (GIK) infusion |
| Primary outcome measure | 30-day mortality (death from any cause and cardiovascular death). |
| Secondary outcome measures | 1. One-year mortality 2. Analysis of pre-specified subgroups |
| Overall study start date | 01/05/2003 |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 900 |
| Key inclusion criteria | 1. Acute myocardial infarction diagnosed by: 1.1. Chest pain suggestive for acute myocardial infarction 1.2. Symptom-onset less than six hours after hospital admission 1.3. Electrocardiogram (ECG) with ST-T segment elevation more than 1 mV in two or more leads 2. Patients are eligible for either primary coronary angioplasty or thrombolysis 3. Patient who has given his or her informed consent to take part in the study |
| Key exclusion criteria | 1. Unwillingness to participate 2. Presence of heart failure (either one of these symptoms): 2.1. Heart rate more than 90 beats/minute 2.2. Systolic blood pressure less than 100 mmHg with anterior myocardial infarction 2.3. Killip class greater than or equal to II (third heart sound, greater than or equal to hand-wide rales) |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/03/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Diagram B.V. Zwolle
Zwolle
8011 NB
Netherlands
8011 NB
Netherlands
Sponsor information
Isala Klinieken (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands
| Website | http://www.isala.nl/Pages/default.aspx |
|---|---|
"ROR" |
https://ror.org/046a2wj10 |
Funders
Funder type
Charity
Netherlands Heart Foundation (The Netherlands)
No information available
Guidant (The Netherlands)
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 | 18/04/2006 | Yes | No |
