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

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

University Hospital Schleswig-Holstein

Collaborator

Robert Bosch-Krankenhaus Stuttgart

Collaborator

Source ClinicalTrials.gov