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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 15, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2027

Conditions
Intensive Care UnitCoronary Artery Bypass Grafting (CABG)High Risk PatientsCardiopulmonary BypassElective Cardiac SurgeryValvular Heart SurgeryMultiple Valve SurgeriesCombined Cardiac ProceduresAortic Surgical Procedures
Interventions
DRUG

Fish Oil

"Omegaven® is a 10% fish oil emulsion with a high percentage of long-chain n-3 fatty acids - mainly eicosapentaenoic acid and docosahexaenoic acid. It optimises the fatty acid pattern in parenteral nutrition and is a source of polyunsaturated n-3 fatty acids as cell membrane components and precursors for eicosanoids.~Omegaven® is manufactured by Fresenius-Kabi, Germany and is available in 100 mL bottles for study purpose.~Each 100 mL of Omegaven® contains 10 g of fish oil (0.1 g/mL).~Timeframe: Day -1: 0.20 g fish oil/kg BW/d (the treatment should be started 24 to 3 h before surgery, can be given as 3-6 hours infusion); intraoperative day 0: no dose; postoperative day 0: 0.20 g fish oil/kg BW/d; postoperative days 1 to max. 7): 0.20 g fish oil/kg BW/d"

DRUG

Intravenous 0.9% Sodium Chloride

Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.

Trial Locations (8)

Unknown

NOT_YET_RECRUITING

University Hospital Augsburg, Augsburg

RECRUITING

Charité Universitätsmedizin Berlin, Berlin

RECRUITING

University of Bonn, Bonn

RECRUITING

University Hospital Goettingen, Göttingen

RECRUITING

University Hospital Hamburg-Eppendorf, Hamburg

RECRUITING

University Medical Center Schleswig-Holstein, Kiel

RECRUITING

University Hospital Mainz, Mainz

RECRUITING

University Hospital Muenster, Münster

All Listed Sponsors
collaborator

University Hospital, Bonn

OTHER

collaborator

University Hospital Muenster

OTHER

collaborator

University Hospital Goettingen

OTHER

collaborator

University Hospital Schleswig-Holstein

OTHER

collaborator

Charite University, Berlin, Germany

OTHER

collaborator

Wuerzburg University Hospital

OTHER

collaborator

Johannes Gutenberg University Mainz

OTHER

collaborator

University Hospital Augsburg

OTHER

collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

lead

GCP-Service International West GmbH

INDUSTRY