drugset / Trial / NCT06279793
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Phase 2
Recruiting
550 enrolled
GCP-Service International West GmbH
Charite University, Berlin, Germany · collabJohannes Gutenberg University Mainz · collabRobert Bosch-Krankenhaus Stuttgart · collabUniversity Hospital Augsburg · collabUniversity Hospital Goettingen · collabUniversity Hospital Muenster · collabUniversity Hospital Schleswig-Holstein · collabUniversity Hospital, Bonn · collabUniversity Medical Center Rostock · collabUniversitätsklinikum Hamburg-Eppendorf · collabWuerzburg University Hospital · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2024-02-15
- Primary completion
- 2030-03
- Completion
- 2030-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fish oil | Other / unclassified | 0.2 g/kg | — |
Indications
No indication recorded.