CTIS2023-503490-38-00招募中1 期
Intravenous Fish Oil based Lipid Emulsion to enhance recovery in High-Risk Cardiac Surgery Patients: a phase II multicenter trial - MODIFY CSX
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Written informed consent prior to study participation, 2. Adult patients (= 18 years), 3. Patients scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) combined valve/coronary artery bypass graft (CABG) or multiple valve surgeries, or combined cardiac/aortic surgical procedures and (ii) 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
- •1. Known hypersensitivity to FO / fish products or egg protein, 8. 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]), 9. Enrolment in any interventional trial within the last 30 days, 12. Severe liver dysfunction defined by Child Pugh Class C., 13. 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, 14. Known severe coagulation disorder, 10. Already receiving FO-containing medical nutrition products, 11. Severe malnutrition (as defined by the body mass index [BMI] <18.5), 2. Pregnancy or lactation period, 3. Previous history of chronic or intermittent atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia, 4. Inability or unwillingness of individual to give written informed consent, 5. Not expected to survive an additional 48 hours from screening evaluation, 6. Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated Do not Resuscitate” (DNR) acceptable), 7. Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma
研究者
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Intravenous Fish Oil based Lipid Emulsion as Pharmaconutrient Strategy in High-Risk Cardiac Surgery Patients: a Phase II Dosing StudyGiven the recently meta-analyzed data from previous RCTs about fish oil , we hypothesize that the provision of intravenous (i.v.) FO (0.20 g/kg and 0.50 g/kg) to cardiac surgery patients may reduce the development of postoperative infections and organ dysfunctions through modulation of cytokines and chemokine release that regulate the activity of various immune cell populations.EUCTR2016-003902-14-DERWTH Aachen University, represented by the Clinical Trial Center (CTC-A)
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