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

NCT ID: NCT00965406

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 772 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-06-30

Brief 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.

Detailed 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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

glucose insulin potassium (GIK)

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

Group Type: PLACEBO_COMPARATOR

GIK and intensive insulin therapy

Intervention Type: DRUG

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

GIK and intensive insulin therapy

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

Group Type: EXPERIMENTAL

GIK and intensive insulin therapy

Intervention Type: DRUG

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

GIK and intensive insulin therapy

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

Intervention Type: DRUG

Other Intervention Names

GIKI2

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Prof. Semir Nouira

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nouira semir, Prof.

Role: PRINCIPAL_INVESTIGATOR

Research Laboratory (LR12SP18) University of Monastir Tunisia

Locations

Mahdia University Hospital

Monastir, Mahdia Governorate, Tunisia

Monastir University Hospital

Monastir, , Tunisia

Sahloul University Hospital

Sousse, , Tunisia

Countries

Tunisia

References

Bouida W, Beltaief K, Msolli MA, Bzeouich N, Sekma A, Echeikh M, Mzali M, Boubaker H, Grissa MH, Boukef R, Hassine M, Dridi Z, Belguith A, Najjar F, Khochtali I, Nouira S; GREAT Network. One-Year Outcome of Intensive Insulin Therapy Combined to Glucose-Insulin-Potassium in Acute Coronary Syndrome: A Randomized Controlled Study. J Am Heart Assoc. 2017 Nov 14;6(11):e006674. doi: 10.1161/JAHA.117.006674.

Reference Type: DERIVED

PMID: 29138181 (View on PubMed)

Other Identifiers

GIKI2

Identifier Type: -

Identifier Source: org_study_id