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

Summary

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.

Conditions

• Aortic Surgical Procedures
• Intensive Care Unit
• Coronary Artery Bypass Grafting (CABG)
• High Risk Patients
• Cardiopulmonary Bypass
• Elective Cardiac Surgery
• Valvular Heart Surgery
• Multiple Valve Surgeries
• Combined Cardiac Procedures
• Adult Patients ≥ 18 Years
• Combined Valve and CABG
• Combined Cardiac and Aortic 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.

Sponsors & Collaborators

• University Hospital, Bonn

  collaborator OTHER

• University Hospital Muenster

  collaborator OTHER

• University Hospital Goettingen

  collaborator OTHER

• University Hospital Schleswig-Holstein

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Wuerzburg University Hospital

  collaborator OTHER

• Johannes Gutenberg University Mainz

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Medical Center Rostock

  collaborator OTHER

• Robert Bosch Medical Center

  collaborator OTHER

• GCP-Service International West GmbH

  lead INDUSTRY

Principal Investigators

• Christian Stoppe, Prof. Dr. · Wuerzburg University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-15

Primary Completion

2030-03-31

Completion

2030-09-30

Countries

• Germany

Study Locations