Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone
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Purpose
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 | Intervention | Phase |
|---|---|---|
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Acute Coronary Syndrome |
Drug: GIK and intensive insulin therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
- 30 days mortality, reinfarction, urgent coronary revascularisation, and stroke. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 772 |
| Study Start Date: | August 2010 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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
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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
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No Intervention: Control group
No intervention and patients were treated with updated international recommendations of acute coronary syndrome.
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00965406
| Tunisia | |
| Mahdia University Hospital | |
| Monastir, Mahdia, Tunisia | |
| Monastir University Hospital | |
| Monastir, Tunisia, 5000 | |
| Sahloul University Hospital | |
| Sousse, Tunisia | |
| Principal Investigator: | nouira semir, Prof. | Research Laboratory (LR12SP18) University of Monastir Tunisia |
More Information
No publications provided
| Responsible Party: | Nouira, Prof. Semir Nouira, University of Monastir |
| ClinicalTrials.gov Identifier: | NCT00965406 History of Changes |
| Other Study ID Numbers: | GIKI2 |
| Study First Received: | August 24, 2009 |
| Last Updated: | December 1, 2014 |
| Health Authority: | Tunisia: Ministry of Public Health |
Keywords provided by University of Monastir:
|
acute coronary syndrome glucose insulin potassium |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Syndrome Angina Pectoris Cardiovascular Diseases Chest Pain Disease Heart Diseases Myocardial Ischemia Pain |
Pathologic Processes Signs and Symptoms Vascular Diseases Insulin Insulin, Globin Zinc Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 26, 2015