Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Recruiting
Phase 2
Interventional Study
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
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 550 (estimated)
- Sponsor
- GCP-Service International West GmbH · Industry
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Written informed consent prior to study participation
2. Adult patients (≥ 18 years)
3. 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 surger…
Contacts