NCT02807727

Cardiac REperfusion With Intralipid® at Reperfusion

Randomised Control Study on Cardiac Protection With Intralipid® in Patients Undergoing Coronary Artery Bypass Grafting on Cardiopulmonary Bypass

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nkanyiso Hadebe · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A single center randomised control study on cardiac protection with INTRALIPD in patients undergoing coronary artery bypass grafting on cardiopulmonary bypass. Purpose and objectives: Reperfusion after coronary artery bypass grafting is associated with a modifiable leak in cardiac Troponin I (cTnI) secondary to ischemia reperfusion injury. The purpose of the study is to test whether INTRALIPID administered at reperfusion can limit myocardial reperfusion injury as measured by cTnI release in patients undergoing coronary artery bypass grafting. Trial design: This study is a prospective single centre double blind placebo controlled randomised trial. Sample size: 30 Adult Male and Female Patients Investigational drug(s): INTRALIPID 20% Fresenius Kabi (SA) Registration Number: K/25.2/316 Formulation: IV Solution Strength: 20% (200mg/ml) Modified Ringer's Lactate Fresenius Kabi (SA) Registration Number: C/24/218 Formulation: IV Solution Dose for both drugs: 1.5 ml/kg Administration: IV Bolus through CVP Blood sampling and tissue biopsies: cTnI will be sampled at fixed time points, baseline 1, 6, 9, 12, 24, 48, and 72 hours after surgery. The first biopsy will be done prior to cardioplegic arrest and the second biopsy will be done 5 minutes after reperfusion. Safety assessments: The safety of the interventions will be monitored routinely for all patients and these will focus on: 1. Changes in the lipid profile after Intralipid 2. Coagulation as measured by ACT, TEG and PFA 3. Oxygenation with Arterial Blood Gas monitoring 4. Hemodynamic monitoring and echocardiography 5. Lipid interference with laboratory measurements. The laboratory will be informed on specimen preparation to avoid interference with instruments 6. Post operative hemodynamic Intensive Care Unit Monitoring Measurement will be reported on all safety monitoring and will be considered adverse events where the measured parameter results are out of range from the laboratory references. Efficacy assessments. Primary endpoint: The efficacy of the drug will be determined by the geometric mean (95% CI) difference in the AUC of the cTnI concentration calculated according to the trapezoid rule. Secondary End Point: Exploring the molecular mechanism involved in cardiac protection by analyzing tissue sample differences in the phosphorylation cytoplasmic protein kinase.

Conditions

• Reperfusion Injury

Interventions

Type	Name	Description
DRUG	Intralipid 20%	Single intravenous bolus dose of 1.5 ml/kg over 3 minutes
DRUG	Modified Ringers Lactate	Single intravenous bolus dose of 1.5 ml/kg over 3 minutes

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-06-21
• Last updated: 2017-12-12

Locations

1 site across 1 country: South Africa