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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing following surgeries

aortic valve replacement (AVR).

mitral valve replacement (MVR).

combined coronary and/or valvular heart surgeries.

Disqualifiers

• right ventricular dysfunction

RV dilatation (RV diameter > 4.5)

RV infarction

pacemaker stimulation,

Trial design

Design model

Parallel

Treatments tested in this trial

  • close pericardium

    Procedure/Surgery

    close pericardium by continuous sutures before sternal closure

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: interventionExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Tricuspid annular plane systolic excursion (TAPSE)

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

Time frame
3 months
2

Tricuspid annular systolic velocity TASV/S'

to asses the effect of pericardial closure on right ventricular function

Time frame
3 month

Secondary outcomes

1

the postoperative LV function after pericardial closure vs. open pericardium

by assessing ejection fraction by early postoperative echocardiography

Time frame
3 months

Other outcomes

Sponsors and contacts

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