Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery

NCT06800781 | Recruiting DMC

• 1 other identifier: 2023-07117-01
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

Brief Summary

Evacuation of pericardial blood by posterior pericardiotomy or use of a posterior pericardial chest tube lowers postoperative atrial fibrillation (POAF) rates after cardiac surgery by 45-68%. Although it cannot be generalized due to trial undersizing, posterior pericardial chest tube treatment may be a superior alternative to pericardiotomy, given its low risk of procedural complications. This interventional multicenter trial will assess whether prolonged treatment with a posterior pericardial chest tube lowers POAF rates after cardiac surgery. Investigators will randomize 624 patients undergoing routine cardiac surgery at Nordic sites 1:1 to receive a posterior pericardial chest tube as adjunct to standard care for up to 3 postoperative days or standard care alone. The primary outcome is the proportion of patients with POAF up to 7 days post-surgery; the study will be powered to detect a relative risk reduction of 30% in the intervention arm. Secondary outcomes are AF burden; days with chest tubes and their output; proportion of patients with POAF up to 14 days post-surgery; direct current conversions during hospital admission; length of ICU/hospital stay; postoperative complications, mortality, ischemic stroke, and major bleeding at 30/90 days and 1/3/5 years; and quality of life/postoperative recovery at 90 days and 1 year. This trial may provide quality clinical evidence supporting the adoption of a simple method to prevent POAF, thus reducing healthcare costs.

Conditions

Valve Replacement; Aortic Surgery; Coronary Arterial Disease (CAD)

Keywords

Posterior pericardial chest tube; Postoperative atrial fibrillation (POAF)

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with POAF the first 7 postoperative days

  The primary endpoint will be defined as the proportion of patients with POAF (an episode of atrial fibrillation (AF) or atrial flutter sustained for \>30 seconds) registred by any available source in the first 7 postoperative days (i.e 12-lead EKG, telemetric monitoring, SmartCardia monitor)

  From enrollment (randomization) to postoperative day 7

Secondary Outcomes (22)

• Proportion of patients with POAF until day 14 postoperative

  From enrollment to postoperative day 14

• Percentage of POAF burden

  From application of SmartCardia monitor until end of recording ((defined as the first 14 postoperative days or battery life of the monitor, whichever is first)

• Proportion of patients with and frequency of DC conversions during hospital admission

  From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first

• Cumulative dose of amiodarone administered during hospital admission

  From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first

• Length of ICU and hospital stay

  From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first

Study Arms (2)

Control: Standard care

NO INTERVENTION

Patients in the control arm will receive 1-2 mediastinal and 0-2 pleural chest tubes (per clinical routine and surgeon's preference). No posterior pericardial chest tube will be inserted in control patients. All other aspects of postoperative care will follow standard clinical routines and will be identical in the intervention and control arms.

Prolonged treatment with posterior pericardial chest tube plus standard of care

EXPERIMENTAL

All patients will receive chest tubes based on each surgeon's preference. Usually, 1 or 2 tubes are inserted in the mediastinum, and 1 is inserted into each open pleural cavity. Patients in the intervention arm will receive an additional posterior 20Ch chest tube.. In cases where the surgeon routinely inserts 2 mediastinal chest tubes, they will use 1-2 anterior mediastinal tubes in the intervention group, based on their preference. The posterior chest tube will be positioned between the inferior aspect of the heart and the pericardium and connected to an active suction system per routine . Once the remaining chest tubes are extracted, the posterior chest tube will remain positioned in the pericardium and be reconnected from active suction to a collection bag for passive drainage. The chest tube will be removed on postoperative Day 3 or when chest tube output is \<50 mL/24 h.

Procedure: Prolonged treatment with posterior pericardial chest tube plus standard care

Interventions

Prolonged treatment with posterior pericardial chest tube plus standard care PROCEDURE

Prolonged treatment with posterior pericardial chest tube plus standard care All patients will receive chest tubes based on each surgeon's preference. Usually, 1 or 2 tubes are inserted in the mediastinum, and 1 is inserted into each open pleural cavity. Patients in the intervention arm will receive an additional posterior 20Ch chest tube. In cases where the surgeon routinely inserts 2 mediastinal chest tubes, they will use 1-2 anterior mediastinal tubes in the intervention group, based on their preference. The posterior chest tube will be positioned between the inferior aspect of the heart and the pericardium and connected to an active suction system per routine. Once the remaining chest tubes are extracted, the posterior chest tube will remain positioned in the pericardium and be reconnected from active suction to a collection bag for passive drainage. The chest tube will be removed on postoperative Day 3 or when chest tube output is \<50 mL/24 h.

Prolonged treatment with posterior pericardial chest tube plus standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Undergoing non-emergent surgery (\>24 hours between decision to operate and surgical procedure) with coronary artery bypass grafting, aortic valve replacement, aortic surgery without the use of circulatory arrest, or any combination of these procedures
• Able to give written informed consent

You may not qualify if:

• History of atrial fibrillation (AF) or atrial flutter
• History of electrophysiological interventions or treatment with antiarrhythmic drugs due to arrhythmias other than AF
• Pre- or postoperative prophylactic treatment with amiodarone
• Existing pacemaker, ICD, or CRT device without a functional atrial lead
• Aortic surgery with hypothermic circulatory arrest
• Previous cardiac surgery
• Previous radiation of the chest due to malignancy
• Ongoing infection at time of surgery
• Ongoing treatment with immunosuppressants, including oral corticosteroids
• Patient already included in another interventional clinical trial
• Patient listed abroad, which would render them to be lost to follow-up after discharge
• Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators.

Sponsors & Collaborators

• Region Skane: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Lund University hospital

Lund, Sweden

RECRUITING

Related Publications (15)

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  PMID: 29174782 BACKGROUND

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  PMID: 20338499 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Igor Zindovic Zindovic, MD, PhD

  Region Skane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Zindovic, MD, Phd

CONTACT

+4646175288; igor.zindovic@skane.se

David Mörtsell, MD, Phd

CONTACT

david.mortsell@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 30, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2033
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)