Cardiac Surgery Clinical Trial
Official title:
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial: A Double-blind, Randomized, Placebo-controlled Trial.
The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only. In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care.
The proposed hypothesize is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation, which ultimately lead to faster time to discharge alive. This 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 Omegaven® in dose 0.20 g/kg/d. Control Group: Patients will receive 0,9% NaCl in dose 0.20 g/kg/d (placebo). Follow-up per patient: at day 30, month 3, 6, and 12 months. Primary endpoint (phase II study): The primary endpoint for this phase II clinical trial will be the presence of new onset atrial fibrillation after cardiac surgery (AFACS) until day 7 after surgery. ;
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