Role of High dose insulin and glucose-potassium-magnesium (HDI-GKM) for Myocardial protection in cardiac surgery - Role of insulin glucose potassium magnesium in cardiac surgery

Conditions: We propose to recruit 90 patients (based on the power calculation) undergoing first time urgent in-house CABG at Morriston Hospital. The decision to operate on an urgent basis will be based on the severity of coronary disease and symptoms. After informed consent, patients will be randomly assigned to eithe rcontrol, HDIGK (High dose Insulin, Glucose, Potassium) or HDIGKM (High dose Insulin, Glucose, Potassium, Magnesium) group according to a random allocation table

Registration Number: EUCTR2004-002850-69-GB

Lead Sponsor: Swansea NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Males or females with symptomatic coronary artery disease, undergoing first time urgent coronary revascularization, categorised as follows:-
Acute Coronary Syndrom: including nonST elevation myocardial infarction (NSETMI), Troponin positive unstable angina and myocardial infarction
Post infarct angina
Severe two or three vessel coronary artery disease or left main stem stenosis requiring revascularization
Severe coronary artery disease with impaired left ventricular function
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 Liver disease
2 Chronic severe renal disease
3 Patients who require procedures in combination with CABG (valve repair/replacement, aneurysm repair)
4 Refusal to give informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the beneficial effects of using Glucose-Insulin-Potassium with Magnesium for myocardial protection during the cardio pulmonary bypass;Secondary Objective: To determine if Insulin alters the inflammatory response of the cardiopulmonary bypass;Primary end point(s): cardiac index to measure cardiac output and Troponin T levels for 24hours after the operation

Secondary Outcome Measures