|
ISRCTN
|
ISRCTN56720616
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Glucose-insulin-potassium infusion in patients treated with primary percutaneous coronary intervention for acute myocardial infarction
|
|
Scientific title
|
|
|
Acronym
|
Glucose-Insulin-Potassium Study (GIPS)
|
|
Serial number at source
|
99.028
|
|
Study hypothesis
|
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).
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Netherlands
|
|
Disease/condition/study domain
|
ST elevation myocardial infarction (mi)
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
Patients were excluded when pre-treated with thrombolysis or when an illness associated with a marked restricted life expectancy was present.
|
|
Anticipated start date
|
01/04/1998
|
|
Anticipated end date
|
30/09/2001
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
940
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
30-day mortality
|
|
Secondary outcome measure(s)
|
Recurrent infarction, repeat coronary angioplasty, and the composite incidence of death, recurrent infarction, or repeat coronary angioplasty.
|
|
Sources of funding
|
Netherlands Heart Foundation (99.028)
|
|
Trial website
|
|
|
Publications
|
2005 results on http://www.ncbi.nlm.nih.gov/pubmed/15932638
|
|
Contact name
|
Prof
Felix
Zijlstra
|
|
Address
|
Hanzeplein 1
|
|
City/town
|
Groningen
|
|
Zip/Postcode
|
30.001
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)503612355
|
|
Email
|
f.zijlstra@thorax.umcg.nl
|
|
Sponsor
|
Netherlands Heart Foundation (Netherlands)
|
|
Address
|
Bordewijklaan 3
|
|
City/town
|
The Hague
|
|
Zip/Postcode
|
300
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)703155555
|
|
Email
|
info@hartstichting.nl
|
|
Sponsor website:
|
http://www.hartstichting.nl/go/
|
|
Date applied
|
17/05/2005
|
|
Last edited
|
15/02/2008
|
|
Date ISRCTN assigned
|
20/05/2005
|
