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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
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
Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.
University Hospital Augsburg
Augsburg, Germany
NOT_YET_RECRUITINGCharité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGUniversity of Bonn
Bonn, Germany
RECRUITINGUniversity Hospital Goettingen
Göttingen, Germany
RECRUITINGUniversity Hospital Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGUniversity Medical Center Schleswig-Holstein
Kiel, Germany
RECRUITINGUniversity Hospital Mainz
Mainz, Germany
RECRUITINGUniversity Hospital Muenster
Münster, Germany
RECRUITINGAtrial fibrillation
The primary objective is to demonstrate superiority of fish oil compared to placebo in the prevention of atrial fibrillation until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.
Time frame: Postoperative days 0-7
Mechanical ventilation
Duration of mechanical ventilation
Time frame: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
Adverse Events
AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs
Time frame: Preoperative day -1 to 12 months follow-up
Delta Sequential Organ Failure Assessment Score (SOFA) Score
A scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.
Time frame: Postoperative days 0-7
Stroke
Incidence of stroke
Time frame: Postoperative days 0-7
Inotropics/vasopressors
Duration of inotropic/vasopressor support
Time frame: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
Acute Kidney Injury
Kidney Disease: Improving Global Outcomes \[KDIGO\] stages 1-3
Time frame: Postoperative days 0-7
Infection rate
Number of infections
Time frame: Postoperative days 0-7
Survival status
Overall survival
Time frame: ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, months 3, 6, and 12 follow-up
Quality of Life (SF-36)
To measure the quality of life
Time frame: Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up
Postoperative bleeding
Bleeding after surgery
Time frame: Postoperative days 0-7
ICU length of stay
Number of days alive in the ICU
Time frame: ICU discharge (approximately 3-4 days after surgery)
Hospital length of stay
Number of days alive in the hospital
Time frame: Hospital discharge (approximately 1-2 weeks after surgery)
Physical activity assessment
Katz activities of daily living (ADL) and Lawton's Instrumental ADL (IADL)
Time frame: Screening (preoperative day -7 until day -1), day 30 follow-up, 3 and 6 months follow-up
Days alive and out of hospital
Time to be alive and discharge from hospital
Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up
Time to discharge alive
Time to be alive and discharged from ICU/hospital
Time frame: ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
Weaning from cardiopulmonary bypass (CPB)
Number of attempts to wean from CPB during surgery
Time frame: Intraoperative day 0 (during surgery)
Persistent Organ Dysfunction + Death
Requiring supportive technologies during the convalescent phase of critical illness
Time frame: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
ICU Readmission rates
Readmission to ICU
Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up
Hospital Readmission rates
Readmission to hospital
Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up
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