Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT06279793
Brief Summary:
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany.
A total of 120 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 be the onset and occurence of atrial fibrillation after cardiac surgery (AFACS) until day 7 after surgery (on ICU and normal ward).
Study:
NCT06279793
Study Brief:
Protocol Section:
NCT06279793