Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Prolonged treatment with posterior pericardial chest tube plus standard care
Procedure/SurgeryProlonged 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.
Treatment groups
624 Participants
are divided into 2 treatment groupsGroup A: Control: Standard careNo intervention 0 interventions
Group B: Prolonged treatment with posterior pericardial chest tube plus standard of careExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
From enrollment (randomization) to postoperative day 7Secondary outcomes
1
Proportion of patients with POAF until day 14 postoperative
Proportion of patients with POAF during the recording period (defined as the first 14 postoperative days or battery life of the monitor, whichever is first)
Time frame
From enrollment to postoperative day 142
Percentage of POAF burden
Percentage of time with POAF (POAF burden) during the whole recording period.
Time frame
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)3
Proportion of patients with and frequency of DC conversions during hospital admission
Time frame
From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first4
Cumulative dose of amiodarone administered during hospital admission
Time frame
From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
The Swedish Research Council
Collaborator
Source ClinicalTrials.gov