Health Trials

Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients

ConditionsIntensive Care UnitCoronary Artery Bypass Grafting (CABG)High Risk PatientsCardiopulmonary BypassElective Cardiac SurgeryValvular Heart SurgeryMultiple Valve SurgeriesCombined Cardiac ProceduresAortic Surgical ProceduresAdult Patients ≥ 18 YearsCombined Valve and CABGCombined Cardiac and Aortic Surgical Procedures
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCP-Service International West GmbH

About this trial

The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy.

A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight (BW) + standard of care versus same volume of placebo (NaCl) + standard of care.

Eligibility criteria

Qualifiers

Written informed consent prior to study participation

Adult patients (≥ 18 years)

Patients scheduled to undergo elective cardiac surgery with the use of CPB, who are defined as high risk based on having (i) one of the following surgical procedures: valvular heart surgery only, CABG, combined valve and CABG, multiple valve surgeries, combined cardiac procedures, aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta) and (ii) at least one of the following additional risk factors: (a) a high perioperative risk profile, defined as predicted operative mortality of ≥8% (EuroSCORE II), (b) age ≥70, (c) Clinical Frailty Score 4 or more, (d) urgent surgery (defined as to be performed within 24-48 hours after admission), (e) left ventricular ejection fraction <35%

Disqualifiers

Known hypersensitivity to fish oil/fish products or egg protein

Pregnancy or lactation period

Previous history of chronic atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia

Inability or unwillingness of individual to give written informed consent

Trial design

Treatments tested in this trial

  • Fish Oil
  • Intravenous 0.9% Sodium Chloride

Treatment groups

550 Participants
are divided into 2 treatment groups

Sponsors and collaborators

GCP-Service International West GmbH

Lead sponsor

University Hospital, Bonn

Collaborator

University Hospital Muenster

Collaborator

University Hospital Goettingen

Collaborator

University Hospital Schleswig-Holstein

Collaborator

Charite University, Berlin, Germany

Collaborator

Wuerzburg University Hospital

Collaborator

Johannes Gutenberg University Mainz

Collaborator

University Hospital Augsburg

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

University Medical Center Rostock

Collaborator

Robert Bosch Medical Center

Collaborator

Source ClinicalTrials.gov