2023-503490-38-00招募中2 期
Intravenous Fish Oil based Lipid Emulsion to enhance recovery in High-Risk Cardiac Surgery Patients: a phase II multicenter trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- AFACS, incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery
研究概览
简要总结
The primary objective is to demonstrate superiority of fish oil (FO) 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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) one of the following surgical procedures: -valvular heart surgery only, -coronary artery bypass graft (CABG), -combined valve and CABG, -multiple valve surgeries, -combined cardiac surgical procedures, -aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta), -combined cardiac and aortic surgical procedures (ii) and at least one of the following additional risk factors: a) a high perioperative risk profile, defined as predicted operative mortality of ≥ 8% (European System for Cardiac Operative Risk Evaluation, EuroSCORE II). b) Age ≥70 c) 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 FO / fish products or egg protein
- •Patients receiving extracorporeal mechanical assist device (e.g. extracorporeal life support systems [ECLS], intra-aortic balloon pump [IABP]) or advanced heart failure therapies (e.g. total artificial heart [TAH], ventricular assist devices [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
- •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)1
- •Known severe coagulation disorder
- •Already receiving special FO-enriched medical nutrition products
- •Severe malnutrition (as defined by the body mass index [BMI] <18.5)
- •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
结局指标
主要结局
AFACS, incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery
AFACS, incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery
次要结局
- Days alive and out of hospital within 30 days
- Number of attempts to wean from CPB during surgery
- Time to hospital discharge alive (TDA)
- Persistent Organ Dysfunction (POD) + Death within 30 days
- Time to ICU discharge alive
- ICU and Hospital Readmission rates
- Delta Sequential Organ Failure Assessment (SOFA) Score
- Duration of mechanical ventilation (invasive and non-invasive)
- Incidence of stroke
- Duration of inotropic/vasopressor/mechanical support
- Acute Kidney Injury (by Kidney Disease: Improving Global Outcomes [KDIGO] stages 1-3)
- Number of infections
- Overall survival
- Physical activity (Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL)
- Quality of Life (Short Form-36 [SF-36])
- Postoperative bleeding
- Adverse events (AEs) leading to discontinuation/AEs at least possibly related to the IMP/Serious adverse events (SAEs)
研究者
sponsor representative
Scientific
Gcp-Service International West GmbH
研究点 (12)
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