Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial - A Randomized, Placebo-controlled Trial -
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 11
- 主要终点
- Atrial fibrillation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients as well as clinical staff and outcome assessors not involved in the study will be blinded to study intervention allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to study participation
- •Adult patients (≥ 18 years)
- •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 surgery only, CABG, combined valve and CABG, multiple valve surgeries, combined cardiac procedures, aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta) and (ii) at least one of the following additional risk factors: (a) a high perioperative risk profile, defined as predicted operative mortality of ≥8% (EuroSCORE II), (b) age ≥70, (c) Clinical Frailty Score 4 or more, (d) urgent surgery (defined as to be performed within 24-48 hours after admission), (e) left ventricular ejection fraction <35%
排除标准
- •Known hypersensitivity to fish oil/fish products or egg protein
- •Pregnancy or lactation period
- •Previous history of chronic atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia
- •Inability or unwillingness of individual to give written informed consent
- •Not expected to survive an additional 48 hours from screening evaluation
- •Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated "Do not Resuscitate" [DNR] acceptable)
- •Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma
- •Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD)
- •Enrolment in any other interventional trial will be discussed with the coordinating investigator on a case-by-case scenario and requires sponsor approval before inclusion
- •Already receiving special FO-enriched medical nutrition products
- •Severe malnutrition (as defined by the BMI <18.5)
- •Severe liver dysfunction defined by Child Pugh Class C.
- •Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR <30ml/min)
- •Known severe coagulation disorder
研究组 & 干预措施
Control group
Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo).
干预措施: Intravenous 0.9% Sodium Chloride (Drug)
Treatment group
Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d).
干预措施: Fish Oil (Drug)
结局指标
主要结局
Atrial fibrillation
时间窗: Postoperative days 0-7
The primary objective is to demonstrate superiority of fish oil compared to placebo in the prevention of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.
次要结局
- Adverse Events(Preoperative day -1 to 12 months follow-up)
- Stroke(Postoperative days 0-7)
- Postoperative bleeding(Postoperative days 0-7)
- Hospital length of stay(Hospital discharge (approximately 1-2 weeks after surgery))
- Days alive and out of hospital(Day 30 follow-up, 3, 6, and 12 months follow-up)
- Time to discharge alive(ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery))
- Weaning from cardiopulmonary bypass (CPB)(Intraoperative day 0 (during surgery))
- Acute Kidney Injury(Postoperative days 0-7)
- Infection rate(Postoperative days 0-7)
- ICU length of stay(ICU discharge (approximately 3-4 days after surgery))
- Quality of Life (SF-36)(Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up)
- Mechanical ventilation(Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up)
- Delta Sequential Organ Failure Assessment Score (SOFA) Score(Postoperative days 0-7)
- Inotropics/vasopressors(Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up)
- Survival status(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)
- Persistent Organ Dysfunction + Death(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(Day 30 follow-up, 3, 6, and 12 months follow-up)
- Hospital Readmission rates(Day 30 follow-up, 3, 6, and 12 months follow-up)
- Physical activity assessment(Screening (preoperative day -7 until day -1), day 30 follow-up, 3 and 6 months follow-up)
- Time to ICU discharge alive(ICU discharge (approximately 3-4 days after surgery))
- Time to hospital discharge alive(Hospital discharge (approximately 1-2 weeks after surgery))