Does the Pericardial Closure Reduces Early Right Ventricular Dysfunction After Cardiac Surgery: A Randomized Controlled 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdelrahamn Hamed Abdelrahman hamed
- Phone Number: 00201060048430
- Email: abdelrahman.hamed.ed@gmail.com
Study Locations
-
-
-
Asyut, Egypt
- Assiut University hospital
-
Contact:
- Assiut Assuit university hospital
- Phone Number: 00201060048430
- Email: abdelrahman.hamed.ed@gmail.com
-
Principal Investigator:
- abdelrahaman hamed Ahmed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention
closed pericardium |
close pericardium by continuous sutures before sternal closure |
|
No Intervention: control
open pericardium |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tricuspid annular plane systolic excursion (TAPSE)
Time Frame: 3 months
|
to asses the effect of pericardial closure on the right ventricular function |
3 months
|
|
Tricuspid annular systolic velocity TASV/S'
Time Frame: 3 month
|
to asses the effect of pericardial closure on right ventricular function |
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the postoperative LV function after pericardial closure vs. open pericardium
Time Frame: 3 months
|
by assessing ejection fraction by early postoperative echocardiography |
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bootsma IT, Scheeren TWL, de Lange F, Jainandunsing JS, Boerma EC. The Reduction in Right Ventricular Longitudinal Contraction Parameters Is Not Accompanied by a Reduction in General Right Ventricular Performance During Aortic Valve Replacement: An Explorative Study. J Cardiothorac Vasc Anesth. 2020 Aug;34(8):2140-2147. doi: 10.1053/j.jvca.2020.01.012. Epub 2020 Jan 15.
- Merlo A, Cirelli C, Vizzardi E, Fiorendi L, Roncali F, Marino M, Merlo M, Senni M, Sciatti E. Right Ventricular Dysfunction before and after Cardiac Surgery: Prognostic Implications. J Clin Med. 2024 Mar 11;13(6):1609. doi: 10.3390/jcm13061609.
- Breuer H, Sales MC, Ramnath NWM, Shieba Y, Kolashov A, Moza A, Tewarie L, Zayat R, Hatam N. Pericardial Closure Preserves Early Right Ventricular Function After Cardiac Surgery: A Retrospective Cohort Study. J Cardiovasc Dev Dis. 2025 Oct 31;12(11):431. doi: 10.3390/jcdd12110431.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pericardial Closure postop
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
according to the need of explanation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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