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Acute Coronary Syndrome | Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone

Acute Coronary Syndrome research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Coronary Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:GIK and intensive insulin therapyGIK 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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.

GIK and intensive insulin therapyGIK 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

Control groupNo intervention and patients were treated with updated international recommendations of acute coronary syndrome.

Study Status

Completed

Start Date: August 2010

Completed Date: June 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: 30 days mortality, reinfarction, urgent coronary revascularisation, and stroke.

Secondary Outcome: 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

Study sponsors, principal investigator, and references

Principal Investigator: nouira semir, Prof.

Lead Sponsor: University of Monastir

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00965406

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