Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients

Официальное название

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 -

Обзор

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.

Подробное описание

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 the onset and occurence of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter, and atrial tachycardia, until day 7 after surgery (on ICU and normal ward).

Вмешательства

• Препарат Fish Oil
  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
• Препарат Intravenous 0.9% Sodium Chloride
  Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.

Первичные конечные точки

• Atrial fibrillation [Срок оценки: Postoperative days 0-7]

Вторичные конечные точки (12)

• Mechanical ventilation [Срок оценки: 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 [Срок оценки: Preoperative day -1 to 12 months follow-up]
• Delta Sequential Organ Failure Assessment Score (SOFA) Score [Срок оценки: Postoperative days 0-7]
• Stroke [Срок оценки: Postoperative days 0-7]
• Inotropics/vasopressors [Срок оценки: 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 [Срок оценки: Postoperative days 0-7]
• Infection rate [Срок оценки: Postoperative days 0-7]
• Survival status [Срок оценки: 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) [Срок оценки: Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up]
• Postoperative bleeding [Срок оценки: Postoperative days 0-7]
• Time to ICU discharge alive [Срок оценки: ICU discharge (approximately 3-4 days after surgery)]
• Time to hospital discharge alive [Срок оценки: Hospital discharge (approximately 1-2 weeks after surgery)]

Критерии участия

Критерии включения

• 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%

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Германия · 10 центров

• University Hospital Augsburg — Augsburg
• Charité Universitätsmedizin Berlin — Berlin
• University of Bonn — Bonn
• University Hospital Goettingen — Göttingen
• University Hospital Hamburg-Eppendorf — Hamburg
• University Medical Center Schleswig-Holstein — Kiel
• University Hospital Mainz — Mainz
• University Hospital Muenster — Münster
• … и ещё 2 центра

Идентификаторы

NCT: NCT06279793 · MODIFY CSX

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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