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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome	Drug: GIK and intensive insulin therapy	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	772 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
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 Start Date :	August 2010
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	June 2014

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: 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.	Drug: 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; Other Name: GIKI2
Experimental: 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	Drug: 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; Other Name: GIKI2
No Intervention: Control group; No intervention and patients were treated with updated international recommendations of acute coronary syndrome.

Outcome Measures

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Primary Outcome Measures :

1. 30 days mortality, reinfarction, urgent coronary revascularisation, and stroke. [ Time Frame: 24 hours ]

Secondary Outcome Measures :

1. 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 [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Tunisia
Mahdia University Hospital
Monastir, Mahdia, Tunisia
Monastir University Hospital
Monastir, Tunisia, 5000
Sahloul University Hospital
Sousse, Tunisia

Sponsors and Collaborators

University of Monastir

Investigators

Principal Investigator:	nouira semir, Prof.	Research Laboratory (LR12SP18) University of Monastir Tunisia

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: e006674. doi: 10.1161/JAHA.117.006674.

Responsible Party:	Pr. Semir Nouira, Prof. Semir Nouira, University of Monastir
ClinicalTrials.gov Identifier:	NCT00965406 History of Changes
Other Study ID Numbers:	GIKI2
First Posted:	August 25, 2009
Last Update Posted:	May 2, 2017
Last Verified:	April 2017

Keywords provided by Pr. Semir Nouira, University of Monastir:

acute coronary syndrome; glucose insulin potassium

Additional relevant MeSH terms:

Syndrome; Acute Coronary Syndrome; Disease; Pathologic Processes; Myocardial Ischemia; Heart Diseases	Cardiovascular Diseases; Vascular Diseases; Insulin, Globin Zinc; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs