Posterior Pericardiotomy for Prevention of POAF After Cardiac Surgery: RCT in Yemen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-06-30

Brief Summary

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A single-center, randomized controlled trial in Yemen evaluating whether posterior pericardiotomy (PP) reduces postoperative atrial fibrillation (POAF) after open-heart surgery. 210 patients undergoing CABG, aortic valve replacement, ascending aortic surgery, or combined procedures were randomized 1:1 to receive either posterior pericardiotomy (PP group, n = 106) or standard care (control group, n = 104). Outcomes assessed included POAF incidence, pericardial effusion, cardiac tamponade, ICU stay, mechanical ventilation, in-hospital mortality, and re-exploration for bleeding or tamponade.

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Detailed Description

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This single-center, prospective randomized controlled trial was conducted at the Cardiovascular and Kidney Transplantation Centre, Taiz University, Yemen. Adult patients undergoing elective open-heart surgery were randomized to receive either posterior pericardiotomy or standard care. The intervention involved creating a longitudinal posterior pericardiotomy incision parallel to the left phrenic nerve to facilitate pericardial drainage into the left pleural cavity.

The study evaluated the impact of posterior pericardiotomy on postoperative atrial fibrillation and related complications, including pericardial effusion and cardiac tamponade, compared with standard surgical management. Participants were monitored during hospitalization and followed for 30 days after surgery to assess clinical outcomes, resource utilization, and mortality.

Conditions

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Postoperative Atrial Fibrillation Cardiac Tamponade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors were blinded to the treatment group; participants and care providers were aware of the intervention.

Study Groups

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Interventional: Posterior Pericardiotomy

A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery. This intervention aims to reduce postoperative atrial fibrillation, pericardial effusion, and cardiac tamponade.

Group Type EXPERIMENTAL

Posterior Pericardiotomy

Intervention Type PROCEDURE

A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.

Control: Standard Care

Conventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type PROCEDURE

Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.

Interventions

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Posterior Pericardiotomy

A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.

Intervention Type PROCEDURE

Standard Care

Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years.
* Elective open-heart surgery:

Coronary artery bypass grafting (CABG) Aortic valve replacement Ascending aortic surgery Combined procedures (e.g., CABG + valve replacement)

Exclusion Criteria

* Previous cardiac or thoracic surgery
* Left-sided pleural adhesions
* Preoperative atrial fibrillation or other rhythm disorders
* Hyperthyroidism
* Renal failure with plasma creatinine \>2.0 mg/dL
* Off-pump CABG
* Mitral or tricuspid valve surgery (excluded due to distinct pathophysiology and POAF risk)
* Refusal to participate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No