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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002850-69-GB

Enrollment

Registered

2005-08-25

Start date

2006-01-06

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Product Name: Dextrose injection BP 50% Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Anhydrous Glucose 50% Current Sponsor code: PL 00039/5661R Product Name: Magnesium Sulphate Inje

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026