Cardiac REperfusion With Intralipid® at Reperfusion

NCT02807727 | Unknown Phase 2 DMC

• 1 other identifier: CREW-I
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• Comparison of the serum Troponin I Leak over 72 hours

  The primary endpoint will be assessed by the geometric mean (95% CI) difference between the protocol and control groups of the area under the curve for the cTnI concentration in serum over 72 hours (sampled at 1, 6, 12, 24, 48 and 72 hours) calculated according to the trapezoid rule.

  Over 72 hours

Secondary Outcomes (1)

• Signaling Pathways of intralipid induced cardiac protection

  5 minutes after reperfusion

Study Arms (2)

Intralipid 20%

ACTIVE COMPARATOR

Intravenous single bolus of 1.5 ml/kg of Intralipid 20% over 3 minutes.

Drug: Intralipid 20%

Modified Ringers Lactate

PLACEBO COMPARATOR

Intravenous single bolus of 1.5 ml/kg of MRL over 3 minutes.

Drug: Modified Ringers Lactate

Interventions

Intralipid 20% DRUG

Single intravenous bolus dose of 1.5 ml/kg over 3 minutes

Also known as: Lipid Emulsion 20%

Intralipid 20%

Modified Ringers Lactate DRUG

Single intravenous bolus dose of 1.5 ml/kg over 3 minutes

Also known as: MRL

Modified Ringers Lactate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nkanyiso Hadebe: lead

Study Sites (1)

Department of Anaesthesia, Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

RECRUITING

Related Publications (1)

• Hadebe N, Cour M, Imamdin A, Petersen T, Pennel T, Scherman J, Snowball J, Ntsekhe M, Zilla P, Swanevelder J, Lecour S. Cardioprotection with Intralipid During Coronary Artery Bypass Grafting Surgery on Cardiopulmonary Bypass: A Randomized Clinical Trial. Cardiovasc Drugs Ther. 2025 Oct;39(5):1045-1052. doi: 10.1007/s10557-024-07594-w. Epub 2024 Jun 12.

  PMID: 38864969 DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nkanyiso E Hadebe, MBBCh

  University of Cape

  STUDY CHAIR

Central Study Contacts

Nkanyiso E Hadebe, MBBCh

CONTACT

0769154990; nkanyiso.hadebe@uct.ac.za

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 21, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)