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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial

Authors: Ahmed A. Abouarab, Jeremy R. Leonard, Lucas B. Ohmes, Christopher Lau, Lisa Q. Rong, Natalia S. Ivascu, Kane O. Pryor, Monica Munjal, Filippo Crea, Massimo Massetti, Tommaso Sanna, Leonard N. Girardi, Mario Gaudino

Published in: Trials | Issue 1/2017

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Abstract

Background

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery. POAF is associated with increased morbidity and hospital costs. We herein describe the protocol for a randomized controlled trial to determine if performing a posterior left pericardiotomy prevents POAF after cardiac surgery.

Methods/design

All patients submitted to cardiac surgery at our institution will be screened for inclusion into the study. The study will consist of two parallel arms with random allocation between groups to either receive a posterior left pericardiotomy or serve as a control. Masking will be done in a single-blinded fashion to the patient. Patients will be continuously monitored postoperatively for the occurrence of atrial fibrillation until discharge. At the follow-up clinic visit (15–30 days after surgery), the primary endpoint (atrial fibrillation) and other secondary endpoints, such as pleural or pericardial effusion, will be assessed. A total sample size of 350 subjects will be recruited.

Discussion

POAF is associated with increased morbidity, prolonged hospital stay, and increased costs after cardiac surgery. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, all with suboptimal results. Posterior left pericardiotomy has been associated with a reduction of POAF in previous series. However, these studies had limited sample sizes and suboptimal methodology, so that the efficacy of posterior pericardiotomy in preventing POAF remains to be definitively proven. Our randomized trial aims to determine the effect of a posterior left pericardiotomy on the incidence of POAF.

Trial registration

ClinicalTrials.gov, ID: NCT02875405, protocol record 1502015867. Registered on July 2016.
Appendix
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Metadata
Title
Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial
Authors
Ahmed A. Abouarab
Jeremy R. Leonard
Lucas B. Ohmes
Christopher Lau
Lisa Q. Rong
Natalia S. Ivascu
Kane O. Pryor
Monica Munjal
Filippo Crea
Massimo Massetti
Tommaso Sanna
Leonard N. Girardi
Mario Gaudino
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2334-4

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