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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Monastir.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Monastir
ClinicalTrials.gov Identifier:
NCT00965406
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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 in patients presenting to the ED with acute coronary syndrome.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: glucose insulin potassium
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

Resource links provided by NLM:


Further study details as provided by University of Monastir:

Primary Outcome Measures:
  • 30 days mortality, reinfarction, urgent coronary revascularisation, and stroke. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severe dysrhythmias, acute left ventricular failure with ejection fraction<45%, change of serum B-type natriuretic peptide (BNP), serum troponin, and platelet factor activator (PFA-100) within 24 hours after the start of protocol treatment. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: August 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GIK
GIK infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours.
Drug: glucose insulin potassium
GIK infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours.
Other Name: GIK
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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965406

Contacts
Contact: nouira semir, MD 73 532 014 semir.nouira@rns.tn
Contact: gamra habib, MD 216 73 447 110 hgamra@rns.tn

Locations
Tunisia
Fattouma Bourguiba University Hospital Not yet recruiting
Monastir, Tunisia, 5000
Contact: Boukef Riadh, MD    216 24 777 445    boukef.riadh@rns.tn   
Contact: bouida wahid, MD    216 73 447 109    bouida.wahid@rns.tn   
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: nouira semir, MD research unit UR06SP21
  More Information

No publications provided

Responsible Party: nouira, research unit UR06SP21
ClinicalTrials.gov Identifier: NCT00965406     History of Changes
Other Study ID Numbers: GIKI2
Study First Received: August 24, 2009
Last Updated: August 24, 2009
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
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014