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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Abdelrahamn Hamed Abdelrahman hamed
- Telefonnummer: 00201060048430
- E-mail: abdelrahman.hamed.ed@gmail.com
Studiesteder
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-
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Asyut, Egypten
- Assiut University hospital
-
Kontakt:
- Assiut Assuit university hospital
- Telefonnummer: 00201060048430
- E-mail: abdelrahman.hamed.ed@gmail.com
-
Ledende efterforsker:
- abdelrahaman hamed Ahmed
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: intervention
closed pericardium |
close pericardium by continuous sutures before sternal closure |
|
Ingen indgriben: control
open pericardium |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tricuspid annular plane systolic excursion (TAPSE)
Tidsramme: 3 months
|
to asses the effect of pericardial closure on the right ventricular function |
3 months
|
|
Tricuspid annular systolic velocity TASV/S'
Tidsramme: 3 month
|
to asses the effect of pericardial closure on right ventricular function |
3 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
the postoperative LV function after pericardial closure vs. open pericardium
Tidsramme: 3 months
|
by assessing ejection fraction by early postoperative echocardiography |
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Pericardial Closure postop
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
according to the need of explanation
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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