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Not Yet Recruiting NCT07836426

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

Conditions: Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac Surgery, Open Heart Surgery

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Assiut University

Location: Assiut University hospital Asyut

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07836426). StuddyBuddy aggregates publicly available trial information.