Condition category
Circulatory System
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
17/10/2007
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

Dr J Klijn

ORCID ID

Contact details

Diagram B.V. Zwolle
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
+31 (0)38 426 2997
j.klijn@diagram-zwolle.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

GIPS II

Study hypothesis

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 two diabetes mellitus (i.e. a history of diabetes mellitus, previously treated with oral hypoglycaemic agents or blood glucose level at admission greater than or equal to 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.

This study will address what the effects will be of metabolic intervention with or without the infusion of GIK on 30-day and one-year mortality in patients eligible for reperfusion therapy (i.e. primary coronary angioplasty or thrombolysis).

Ethics approval

Approval received from the local ethics committee (Medisch Ethische Toetsings Commissie) on the 2nd May 2003 (ref: 02.1280).

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute myocardial infarction

Intervention

An infusion of 80 mmol potassium chloride in 500 ml 20% glucose with a rate of 2 ml/kilogram body weight/hour over an 12 hour period in a peripheral venous line. 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.

The insulin infusion will be stopped one hour prior to the discontinuation of the glucose-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.

Intervention type

Drug

Phase

Not Specified

Drug names

Glucose-Insulin-Potassium (GIK) infusion

Primary outcome measures

30-day mortality (death from any cause and cardiovascular death).

Secondary outcome measures

1. One-year mortality
2. Analysis of pre-specified subgroups

Overall trial start date

01/05/2003

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute myocardial infarction diagnosed by:
1.1. Chest pain suggestive for acute myocardial infarction
1.2. Symptom-onset less than six hours after hospital admission
1.3. Electrocardiogram (ECG) with ST-T segment elevation more than 1 mV in two or more leads
2. Patients are eligible for either primary coronary angioplasty or thrombolysis
3. Patient who has given his or her informed consent to take part in the study

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

900

Participant exclusion criteria

1. Unwillingness to participate
2. Presence of heart failure (either one of these symptoms):
2.1. Heart rate more than 90 beats/minute
2.2. Systolic blood pressure less than 100 mmHg with anterior myocardial infarction
2.3. Killip class greater than or equal to II (third heart sound, greater than or equal to hand-wide rales)

Recruitment start date

01/05/2003

Recruitment end date

01/03/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Diagram B.V. Zwolle
Zwolle
8011 NB
Netherlands

Sponsor information

Organisation

Isala Klinieken (The Netherlands)

Sponsor details

Locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.isala.nl/Pages/default.aspx

Funders

Funder type

Charity

Funder name

Netherlands Heart Foundation (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Guidant (The Netherlands)

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?db=PubMed&cmd=Retrieve&list_uids=16631017

Publication citations

  1. Results

    Timmer JR, Svilaas T, Ottervanger JP, Henriques JP, Dambrink JH, van den Broek SA, van der Horst IC, Zijlstra F, Glucose-insulin-potassium infusion in patients with acute myocardial infarction without signs of heart failure: the Glucose-Insulin-Potassium Study (GIPS)-II., J. Am. Coll. Cardiol., 2006, 47, 8, 1730-1731, doi: 10.1016/j.jacc.2006.01.040.

Additional files

Editorial Notes