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Trial record 59 of 180 for:    Phospholipids

Cardiac REperfusion With Intralipid® at Reperfusion (CREW-I)

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ClinicalTrials.gov Identifier: NCT02807727
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Nkanyiso Hadebe, University of Cape Town

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.

Condition or disease Intervention/treatment Phase
Reperfusion Injury Drug: Intralipid 20% Drug: Modified Ringers Lactate Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Control Study on Cardiac Protection With Intralipid® in Patients Undergoing Coronary Artery Bypass Grafting on Cardiopulmonary Bypass
Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intralipid 20%
Intravenous single bolus of 1.5 ml/kg of Intralipid 20% over 3 minutes.
Drug: Intralipid 20%
Single intravenous bolus dose of 1.5 ml/kg over 3 minutes
Other Name: Lipid Emulsion 20%

Placebo Comparator: Modified Ringers Lactate
Intravenous single bolus of 1.5 ml/kg of MRL over 3 minutes.
Drug: Modified Ringers Lactate
Single intravenous bolus dose of 1.5 ml/kg over 3 minutes
Other Name: MRL




Primary Outcome Measures :
  1. Comparison of the serum Troponin I Leak over 72 hours [ Time Frame: 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.


Secondary Outcome Measures :
  1. Signaling Pathways of intralipid induced cardiac protection [ Time Frame: 5 minutes after reperfusion ]
    Two right atrial and two left ventricular biopsies will be collected before cardioplegia and the second will be collected 5 minutes prior to reperfusion. These will be used to compare the activation of signalling protein between the groups.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807727


Contacts
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Contact: Nkanyiso E Hadebe, MBBCh 0769154990 nkanyiso.hadebe@uct.ac.za

Locations
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South Africa
Department of Anaesthesia, Groote Schuur Hospital Recruiting
Cape Town, Western Cape, South Africa, 7925
Contact: Nkanyiso E Hadebe, MBBCh    0769154990    nkanyiso.hadebe@uct.ac.za   
Sponsors and Collaborators
Nkanyiso Hadebe
Investigators
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Study Chair: Nkanyiso E Hadebe, MBBCh University of Cape

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Responsible Party: Nkanyiso Hadebe, Dr, University of Cape Town
ClinicalTrials.gov Identifier: NCT02807727     History of Changes
Other Study ID Numbers: CREW-I
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data will not be shared

Additional relevant MeSH terms:
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Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions