ISRCTN11243508进行中（未招募）Unknown
Endothelial Dysfunction, Inflammation and Oxidative Stress (EDIOS) in patients undergoing cardiac surgery with pulsatile or non-pulsatile cardiopulmonary bypass: a multi-centric randomised controlled trial
Slovenian Research and Innovation Agency0 个研究点目标入组 144 人开始时间: 2024年5月21日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
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
- 性别
- All
入选标准
- •1. Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
- •2. Expected aortic cross-clamp (ACC) time of >45 minutes
- •3. Full or partial median sternotomy with central cannulation (mini-CPB should not be used)
- •4. surgery starting in the morning:
- •4.1. Cardiac valve surgery
- •4.2. Isolated coronary artery bypass grafting (CABG)
- •4.3. Combination of valvular and CABG surgery
- •4.4. Any of the above combined with ascending aorta surgery
- •(NO concomitant radio-frequency ablations, NO concomitant carotid artery surgery)
排除标准
- •1. Refusal to participate in the study
- •2. Pregnant women
- •3. Patients with previous cardiac surgery (i.e., redo surgery)
- •4. Patients with left ventricular ejection fraction <30%
- •5. Patients on chemo/immunosuppressive therapy (including inhaled corticosteroids, antileukocyte drugs or TNF-a blockers)
- •6. Patients with body mass index, >35 kg·m-2 or <18 kg·m-2
- •7. Patients with a body surface area (BSA - duBois formula) >2.20 m2 (as it would be impossible to achieve pulsatile pump flow equivalent to a cardiac index of 2.0-2.4, without exceeding maximum safe line pressure in the extracorporeal circuit)
- •8. Patients with any autoimmune diseases, immunocompromised patients (e.g., with AIDS) or with leucopoenia (<3.5·109 cells·L-1)
- •9. Clinical and/or laboratory signs of infection
- •10. Patients with advanced chronic lung disease with pO2 on air: <9.8 kPa
- •11. Patients with known liver disease (albumin <30 g/L; bilirubin >34.2µmol·L-1)
- •12. Patients with renal failure (serum creatinine >176 µmol·L-1)
- •13. Patients with malignant diseases within the last 5 years (i.e., remission or cure 5 years or longer)
- •14. Patients with ischemic stroke or myocardial infarction (STEMI) within the last 3 months
- •15. Patients with known epilepsy
- •16. Patients with known allergy to any drugs used in the study protocol
- •Exclusion criteria - after enrolment:
- •Two analyses will be performed, one based on the treatment received and the second one with the additional exclusion criteria which could have an additional effect on the measured outcomes of endothelial dysfunction, inflammation, and/or oxidative stress; for example, patients who received systemic glucocorticoid medication before the last blood sampling.
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