NCT06279793

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

Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial - A Randomized, Placebo-controlled Trial -

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: GCP-Service International West GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed hypothesis is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation, which ultimately leads to faster time to discharge alive. This in turn significantly improves the patients' mid and long-term outcomes and dramatically reduces associated healthcare related costs. Duration of intervention: until discharge from ICU, death or postoperative day 7 on ICU, whichever comes first. Treatment Group: Patients will receive 0.20 g fish oil/kg BW/d (≙ 2 mL Omegaven®/kg BW/d). Control Group: Patients will receive 0,9% NaCl in dose 2 mL/kg BW/d (placebo). Follow-up per patient: at day 30, months 3, 6, and 12. Primary endpoint (Phase II study): The primary endpoint for this phase II clinical trial is the onset and occurence of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter, and atrial tachycardia, until day 7 after surgery (on ICU and normal ward).

Conditions

• 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
• Aortic Surgical Procedures
• Adult Patients ≥ 18 Years
• Combined Valve and CABG
• Combined Cardiac and Aortic Surgical Procedures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-15
• Primary completion: 2030-03-01
• Completion: 2030-09-01
• First posted: 2024-02-28
• Last updated: 2026-02-23

Locations

10 sites across 1 country: Germany