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).
ID
Bron
Verkorte titel
Aandoening
Acute myocardial infarction eligible for reperfusion therapy.
Ondersteuning
Groningen, Academisch Ziekenhuis Dr S.A.J. van den Broek
AMC Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
30-day mortality (death from any cause and cardiovascular (death).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Wetenschappelijk
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL84 |
NTR-old | NTR114 |
Ander register | : |
ISRCTN | ISRCTN08189331 |
Samenvatting resultaten
2. J Am Coll Cardiol. 2006 Apr 18;47(8):1730-1. Epub 2006 Mar 27. <br>
3. Int J Cardiol. 2007 Oct 31;122(1):52-5. Epub 2007 Jan 16. <br>