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

Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone in the Early Management of Acute Coronary Syndrome: Randomised Controlled Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00965406
Enrollment
772
Registered
2009-08-25
Start date
2010-08-31
Completion date
2014-06-30
Last updated
2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome, glucose insulin potassium

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.

Interventions

DRUGGIK 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

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
30 days mortality, reinfarction, urgent coronary revascularisation, and stroke.24 hours

Secondary

MeasureTime frame
Severe dysrhythmias, acute left ventricular failure with ejection fraction<45%, serum troponin, PAI level and platelet factor activator (PFA-100) within 24 hours after the start of protocol treatment. Safety: major or minor hypoglycemia24 hours

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026