Clinical trial NCT00965406: Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone
Official title: Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone in the Early Management of Acute Coronary Syndrome: Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
glucose insulin potassium
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 30 days mortality, reinfarction, urgent coronary revascularisation, and stroke.
timeFrame: 24 hours
Secondary outcomes:
measure: 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 hypoglycemia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Mahdia University Hospital
state: Mahdia
city: Monastir
country: Tunisia
facility: Monastir University Hospital
city: Sousse
country: Tunisia
facility: Sahloul University Hospital
Study officials:
affiliation: Research Laboratory (LR12SP18) University of Monastir Tunisia
name: nouira semir, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.