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

NCT00965406 | Completed Phase 3

• 1 other identifier: GIKI2
• Study Type: interventional
• Target: 772
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome; glucose insulin potassium

Outcome Measures

Primary Outcomes (1)

• 30 days mortality, reinfarction, urgent coronary revascularisation, and stroke.

  24 hours

Secondary Outcomes (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

  24 hours

Study Arms (3)

glucose insulin potassium (GIK)

PLACEBO COMPARATOR

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 and intensive insulin therapy

EXPERIMENTAL

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

Control group

NO INTERVENTION

No intervention and patients were treated with updated international recommendations of acute coronary syndrome.

Interventions

GIK and intensive insulin therapy DRUG

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

Also known as: GIKI2

GIK and intensive insulin therapy; glucose insulin potassium (GIK)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients fulfilling ACS criteria with or without known diabetes.

You may not qualify if:

• Patients under 18 years old.
• Killip II class or SaO2 ≤ 90%.
• Blood creatinine ≥ 180 µmol/L
• Potassium serum ≥ 6.5 mmol/L.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (3)

Mahdia University Hospital

Monastir, Mahdia Governorate, Tunisia

Location

Monastir University Hospital

Monastir, 5000, Tunisia

Location

Sahloul University Hospital

Sousse, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 29138181 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• nouira semir, Prof.

  Research Laboratory (LR12SP18) University of Monastir Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Semir Nouira

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

TU (3)