Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone

Last updated: April 28, 2017
Sponsor: University of Monastir
Overall Status: Completed

Phase

3

Condition

Chest Pain

Myocardial Ischemia

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00965406
GIKI2
  • Ages > 18
  • All Genders

Study Summary

The aim of this study is to evaluate the effect of the glucose insulin potassium (GIK) infusion associated with intensive insulin therapy compared to GIK alone and control group in patients presenting to the ED with acute coronary syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients fulfilling ACS criteria with or without known diabetes.

Exclusion

Exclusion Criteria:

  • Patients under 18 years old.

  • Killip II class or SaO2 ≤ 90%.

  • Blood creatinine ≥ 180 µmol/L

  • Potassium serum ≥ 6.5 mmol/L.

Study Design

Total Participants: 772
Study Start date:
August 01, 2010
Estimated Completion Date:
June 30, 2014

Study Description

It is well recognised that diabetes is a factor of worse prognosis in acute coronary syndrome (ACS). Recently, the relationship between the glucidic metabolism and cardiac ischemia was highlighted whether patients have diabetes or not. Indeed, it was established that hyperglycemia occurring during hospitalization in non diabetic patients, is a powerful risk factor of death.

Stress related hyperglycemia occurs during number of acute pathological situations (AMI, stroke, pancreatitis, hypothermia, hypoxia, cirrhosis, polytrauma, burn, sepsis…. It is due to an excess of hyperglycemia hormones (glucagon, growth hormone, catecholamines and glucosteroids) and of inflammatory mediators (cytokines…). Hyperglycemia has several deleterious effects on the cardiovascular system as it promotes microvascular inflammatory reaction, activation of the coagulation system, and free radical oxygen liberation.

Currently, the idea of controlling glycemia in surgical and medical intensive care patients is widely accepted and maintaining blood sugar level closest to normal by intensive insulin therapy became largely recommended.

Several decades ago, glucose-insulin-potassium infusion (GIK) was proposed to protect acute cardiac ischemia. GIK has been assessed in many previous studies.

The results of these studies are contradictory. According to CREATE-ECLA study which is the largest (including 20201 patients), GIK didn't show a significant beneficial effect in ACS. However, in these trials using GIK alone glycemia was not strictly controlled.

Recently, the importance of tight glycemic control has been highlighted in ICU patients and early post heart surgery. Our hypothesis is that GIK treatment associated to intensive insulin therapy in ACS would be beneficial and superior to GIK alone possibly because intensive insulin therapy would prevent potential deleterious effects of hyperglycemia induced by GIK.

Connect with a study center

  • Mahdia University Hospital

    Monastir, Mahdia
    Tunisia

    Site Not Available

  • Monastir University Hospital

    Monastir, 5000
    Tunisia

    Site Not Available

  • Sahloul University Hospital

    Sousse,
    Tunisia

    Site Not Available

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