Condition category
Circulatory System
Date applied
17/05/2005
Date assigned
20/05/2005
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hartstichting.nl/go/

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

  1. 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.

Additional files

Editorial Notes