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

University of Monastir

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Drug: GIK and intensive insulin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00965406

GIKI2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 772 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients under 18 years old.
• Killip II class or SaO2 ≤ 90%.
• Blood creatinine ≥ 180 µmol/L
• Potassium serum ≥ 6.5 mmol/L.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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772 participants in 3 patient groups, including a placebo group

glucose insulin potassium (GIK)

Placebo Comparator group

Description:

Glucose + insulin +6 potassium (GIK) infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours.

Treatment:

Drug: GIK and intensive insulin therapy

GIK and intensive insulin therapy

Experimental group

Description:

GIK infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours. Intravenous intensive insulin therapy is simultaneously administered according to our protocol in the ED

Treatment:

Drug: GIK and intensive insulin therapy

Control group

No Intervention group

Description:

No intervention and patients were treated with updated international recommendations of acute coronary syndrome.