Does the Pericardial Closure Reduces Early Right Ventricular Dysfunction After Cardiac Surgery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Tricuspid annular plane systolic excursion (TAPSE)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •• 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.
Arms & Interventions
intervention
closed pericardium
Intervention: close pericardium (Procedure)
control
open pericardium
Outcomes
Primary Outcomes
Tricuspid annular plane systolic excursion (TAPSE)
Time Frame: 3 months
to asses the effect of pericardial closure on the right ventricular function
Tricuspid annular systolic velocity TASV/S'
Time Frame: 3 month
to asses the effect of pericardial closure on right ventricular function
Secondary Outcomes
- the postoperative LV function after pericardial closure vs. open pericardium(3 months)
Investigators
Abdelrahman Hamed Ahmed
Abdelrahaman Hamed Ahmed Mohamed
Assiut University
