Contact information
Type
Scientific
Primary contact
Prof Felix Zijlstra
ORCID ID
Contact details
Hanzeplein 1
Groningen
30.001
Netherlands
+31 (0)503612355
f.zijlstra@thorax.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
99.028
Study information
Scientific title
Acronym
Glucose-Insulin-Potassium Study (GIPS)
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).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
glucose-insulin-potassium
Primary outcome measures
30-day mortality
Secondary outcome measures
Recurrent infarction, repeat coronary angioplasty, and the composite incidence of death, recurrent infarction, or repeat coronary angioplasty.
Overall trial start date
01/04/1998
Overall trial end date
30/09/2001
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
940
Participant exclusion criteria
Patients were excluded when pre-treated with thrombolysis or when an illness associated with a marked restricted life expectancy was present.
Recruitment start date
01/04/1998
Recruitment end date
30/09/2001
Locations
Countries of recruitment
Netherlands
Trial participating centre
Hanzeplein 1
Groningen
30.001
Netherlands
Sponsor information
Organisation
Netherlands Heart Foundation (Netherlands)
Sponsor details
Bordewijklaan 3
The Hague
300
Netherlands
+31 (0)703155555
info@hartstichting.nl
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Netherlands Heart Foundation (99.028)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results on http://www.ncbi.nlm.nih.gov/pubmed/15932638
Publication citations
-
Results
van der Horst IC, Ottervanger JP, van 't Hof AW, Reiffers S, Miedema K, Hoorntje JC, Dambrink JH, Gosselink AT, Nijsten MW, Suryapranata H, de Boer MJ, Zijlstra F, The impact of glucose-insulin-potassium infusion in acute myocardial infarction on infarct size and left ventricular ejection fraction [ISRCTN56720616]., BMC Med, 2005, 3, 9, doi: 10.1186/1741-7015-3-9.