Does the Pericardial Closure Reduces Early Right Ventricular Dysfunction After Cardiac Surgery: A Randomized Controlled Trial
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
closed pericardium
干预措施: close pericardium (Procedure)
control
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
Abdelrahman Hamed Ahmed
Abdelrahaman Hamed Ahmed Mohamed
Assiut University
