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临床试验/NCT07836426
NCT07836426尚未招募不适用

Does the Pericardial Closure Reduces Early Right Ventricular Dysfunction After Cardiac Surgery: A Randomized Controlled Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Tricuspid annular plane systolic excursion (TAPSE)

研究概览

简要总结

The right ventricular (RV) function has a major influence on the outcomes of cardiac surgery[1,2]. Also affects the prognosis of patients undergoing heart surgery, where the development of right ventricular failure after surgery is linked to higher rates of morbidity and mortality[3]. Significant clinical consequences result from perioperative impairment of RV function, including increased need for inotropic support, prolonged intensive care unit admission, higher rates of hospital readmission, and a higher risk of in-hospital mortality.[2,4]. Regardless of the use of cardiopulmonary bypass, longitudinal evaluations of RV systolic function, such as tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular systolic velocity (TASV/S'), frequently decrease following elective coronary artery bypass grafting (CABG) [6,7]. Loss of pericardial restriction during pericardiotomy, ischemia from inadequate myocardial protection, and postoperative adhesions that modify RV shape and contraction patterns are theories explaining these perioperative alterations [4,8]. This study employed standard transthoracic echocardiography and speckle-tracking deformation analysis for the assessment of the effect of closing the pericardium on RV function post operatively versus leaving it open.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing following surgeries
  • •aortic valve replacement (AVR).
  • •mitral valve replacement (MVR).
  • •combined coronary and/or valvular heart surgeries.
  • •coronary artery by-pass graft (CABG).

排除标准

  • •• right ventricular dysfunction
  • •RV dilatation (RV diameter > 4.5)
  • •RV infarction
  • •pacemaker stimulation,
  • •severe left heart insufficiency (LV-EF ≤ 40%).
  • •tricuspid valve insufficiency > 2°.
  • •pulmonary valve insufficiency ≥2°,
  • •atrial fibrillation/flutter,
  • •pulmonary hypertension,
  • •state after pulmonary artery embolism.
  • •chronic obstructive pulmonary disease > GOLD 2, prior cardiac surgery.

研究组 & 干预措施

intervention

Experimental

closed pericardium

干预措施: close pericardium (Procedure)

control

No Intervention

open pericardium

结局指标

主要结局

Tricuspid annular plane systolic excursion (TAPSE)

时间窗: 3 months

to asses the effect of pericardial closure on the right ventricular function

Tricuspid annular systolic velocity TASV/S'

时间窗: 3 month

to asses the effect of pericardial closure on right ventricular function

次要结局

  • the postoperative LV function after pericardial closure vs. open pericardium(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelrahman Hamed Ahmed

Abdelrahaman Hamed Ahmed Mohamed

Assiut University

研究点 (1)

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