Cardiac REperfusion With Intralipid® at Reperfusion

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the benefit of Intralipid® or placebo administered prior to reperfusion to limit ischemia reperfusion injury as measured by the geometric mean difference of the release of troponin I over 72 hours after coronary artery bypass.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nkanyiso Hadebe
• Treatments: Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• First time elective isolated CABG

• Ejection Fraction greater the 40 by echocardiography or subjectively judged as preserved or good by ventriculography.

• Male and female adults between 18 and 65 years of age.

• Women must have a negative serum pregnancy test at screening.

• Body mass Index (BMI) between 21 and 35 kg/m2.

• Baseline clinical laboratory tests at screening within the reference ranges

Exclusion Criteria:

• Received an investigational drug or participated in another research trial within 30 days before the first dose of trial drug or at any time throughout the trial.

• Evidence of current or history of clinically significant oncologic, pulmonary, hepatic with elevated liver functions enzymes 1.5* Upper Limit of Normal (ULN), cardiovascular, haematologic, metabolic, neurological, immunologic, nephrologic, endocrine particularly Diabetes Mellitus as defined by the American Diabetic Association, psychiatric disease, or clinically significant current infection.

• Patients with renal impairment with a creatinine greater than 200 μmol/L

• Evidence of current or history of clinically significant gastrointestinal (excluding appendectomy, cholecystectomy) disease.

• Myocardial infarction within the previous 2 weeks.

• Patients who require inotropic or mechanical cardiac support prior to anaesthesia.

• Contraindication to the trial drugs Previous Hypertriglyceridemia pancreatitis. Hypertriglyceridemia with plasma triglyceride levels > 5.7mmol/L Egg, peanut and soybean allergy.