|- candidate number||1184|
|- NTR Number||NTR114|
|- Date ISRCTN created||26-feb-2007|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||12-aug-2005|
|- Secondary IDs|| |
|- Public Title||Metabolic control with glucose-insulin-potassium infusion in acute myocardial infarction (GIPS II).|
|- Scientific Title||Metabolic control with glucose-insulin-potassium infusion in acute myocardial infarction (GIPS II).|
|- ACRONYM||GIPS II|
|- hypothesis||The study will address what the effects will be of metabolic intervention with or without the infusion of GIK on 30-day and 1-year mortality in patients eligible for reperfusion therapy (i.e. primary coronary angioplasty or thrombolysis). |
|- Healt Condition(s) or Problem(s) studied||Acute myocardial infarction |
|- Inclusion criteria||Acute myocardial infarction diagnosed by:|
1. Chest pain suggestive for acute myocardial infarction;
2. Symptom-onset < 6 hour after hospital admission;
3. ECG with ST-T segment elevation > 1 mV in 2 or more leads.
Patients are eligible for either primary coronary angioplasty or thrombolysis.
Patient who has given his or her informed consent to take part in the study.
|- Exclusion criteria||1. Unwillingness to participate;|
2. Presence of heart failure (either one of these symptoms):
a. Heart rate, > 90 beats/min;
b. Systolic blood pressure < 100 mmHg with anterior myocardial infarction;
c. Killip „d II (third heart sound, „d hand-wide rales).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2003|
|- planned closingdate||1-mrt-2006|
|- Target number of participants||900|
|- Interventions||An infusion of 80 mmol potassium chloride in 500 ml 20 percent glucose with a rate of 2 ml/kilogram body weight/hour over an 12 hour period in a peripheral venous line (Appendix 1).|
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 (see appendix).
The insulin infusion will be stopped 1 hour prior to the discontinuation of the glucose ¡V 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.
|- Primary outcome||30-day mortality (death from any cause and cardiovascular (death). |
|- Secondary outcome||Secondary endpoints are one-year mortality, and analysis of pre-specified subgroups.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| J. Klijn|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.P. Ottervanger|
|- Sponsor/Initiator ||Isala Klinieken, Locatie Weezenlanden, Department of Cardiology|
(Source(s) of Monetary or Material Support)
|- Publications||1. BMC Med. 2005 Jun 2;3:9. |
2. J Am Coll Cardiol. 2006 Apr 18;47(8):1730-1. Epub 2006 Mar 27.
3. Int J Cardiol. 2007 Oct 31;122(1):52-5. Epub 2007 Jan 16.
|- Brief summary||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 2 diabetes mellitus (i.e. a history of diabetes mellitus, previously treated with oral hypoglycaemic agents or bloodglucose level at admission „d 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.
|- Main changes (audit trail)|
|- RECORD||5-aug-2005 - 6-nov-2008|