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

ABSTRACT: 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.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.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.ClinicalTrials.gov, ID: NCT02875405 , protocol record 1502015867. Registered on July 2016.

SUBMITTER: Abouarab AA

PROVIDER: S-EPMC5729517 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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

Abouarab Ahmed A AA Leonard Jeremy R JR Ohmes Lucas B LB Lau Christopher C Rong Lisa Q LQ Ivascu Natalia S NS Pryor Kane O KO Munjal Monica M Crea Filippo F Massetti Massimo M Sanna Tommaso T Girardi Leonard N LN Gaudino Mario M

Trials 20171213 1

<h4>Background</h4>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.<h4>Methods/design</h4>All patients submitted to cardiac surgery at our institution will be screened for inclusion into the study. The study will consist of two pa ...[more]

PMID: 29237510

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Project description:Postoperative atrial fibrillation (POAF) is a common complication of cardiac surgery. It has been proven to be associated with an increase in the incidence of early complications and mortality, an increase in the rate of hospital stay duration, and economic costs of their treatment. One of the pharmaceutical drugs recommended by the American College of Cardiology (ACC)/American Heart Association (AHA) for preventing POAF is colchicine (class IIB). However, the results of research on the efficacy and safety of colchicine are ambiguous and, consequently, require further study. Evaluating the efficacy of short-term colchicine administration in the prevention of POAF in patients after open-heart surgery. Double-blind, randomized, placebo-controlled clinical trial. The subjects were randomly assigned to two groups: treatment group (n = 50) with subjects receiving 1 mg of colchicine 24 h before the surgery, as well as on days 2, 3, 4, and 5 in the postoperative period; and the control group (n = 51), receiving placebo on the same schedule. The primary endpoint was the frequency of POAF in both groups within 7 days after surgery. The study included 101 patients (82 men, 19 women). Baseline clinical, laboratory, instrumental, and intraoperative data did not differ statistically significantly between the groups. POAF was detected in 9 patients (18%) of the treatment group and 15 subjects (29.4%) of the control group, which had no statistical significance (odds ratio, OR 0.527; 95% Cl 0.206-1.349; p = 0.178). No statistically significant differences were revealed for most secondary endpoints, as well as between the groups for all laboratory parameters. There were statistically significant differences between the groups solely in the frequency of diarrhea: 16 (32%) patients in the treatment group and 6 (11.8%) subjects in the control group (OR 3.529; 95% Cl 1.249-9.972; p = 0.010). We did not detect any statistical differences between the groups in terms of primary endpoints, which could be due to the insufficient volume of the sample of the study. However, we detected some trends of statistical differences among the groups in terms of some parameters. Unique identifier: NCT04224545.

Dataset Information

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

Publications

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

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