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Short-Term Atrial Pacing and Hemodynamics After Cardiac Surgery

ConditionCardiac Output
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint-Joseph University

About this trial

The goal of this clinical trial is to learn whether temporary atrial pacing improves heart function after cardiac surgery under cardiopulmonary bypass (CPB). It will also help determine the best pacing rate during the first 24 hours after surgery. The main questions it aims to answer are:

* Does atrial pacing improve cardiac output after surgery? * Is 70, 80, or 90 bpm the most effective pacing rate? * Does pacing reduce the risk of atrial fibrillation after surgery?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or older

Cardiac surgery under CPB (coronary artery bypass grafting, valve replacement or repair, or combined procedures)

Placement of epicardial atrioventricular pacing wires during surgery

Placement of a Swan-Ganz catheter intraoperatively

Disqualifiers

Emergency surgery

Patients with an internal pacemaker

History of permanent atrial fibrillation

Complete atrioventricular block upon weaning from CPB

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pacing Protocol for Pacing Group

    Procedure/Surgery

    At four standardized time points (H0: arrival in the ICU, H6, H12, H24), a transient pacing sequence at 70, 80, and 90 bpm is conducted, with each rate applied for 10 minutes to allow stabilization, followed by recording of the hemodynamic profile and blood pressure, as follows: * If the patient has a spontaneous rhythm between 50 and 69 bpm, measurements are taken at the spontaneous rate, then at 70 bpm, 80 bpm, and finally 90 bpm * If the patient has a spontaneous rhythm between 70 and 79 bpm, measurements are taken at the spontaneous rate, then at 80 bpm, and finally at 90 bpm * If the patient has a spontaneous rhythm between 80 and 89 bpm, measurements are taken at the spontaneous rate, then at 90 bpm * If the patient has a spontaneous rhythm ≥ 90 bpm, measurements are taken at the spontaneous rate only

  • Pacing Protocol for Non-pacing Group

    Procedure/Surgery

    At H0, H6, H12, and H24, they will undergo transient pacing at 70, 80, and 90 bpm, following the same measurement protocol (10 minutes per rate), followed by recording of the hemodynamic profile and blood pressure, as follows: * If the patient has a rhythm between 50 and 69 bpm, measurements will be taken at the spontaneous rate, then at 70 bpm, 80 bpm, and finally 90 bpm * If the patient has a rhythm between 70 and 79 bpm, measurements will be taken at the spontaneous rate, then at 80 bpm, and finally at 90 bpm * If the patient has a rhythm between 80 and 89 bpm, measurements will be taken at the spontaneous rate, then at 90 bpm * If the patient has a rhythm ≥ 90 bpm, measurements will be taken at the spontaneous rate only Outside the pacing periods at different rates, patients in the non-pacing group will remain on their spontaneous sinus rhythm.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Pacing GroupPlacebo comparator 1 intervention
Group B: Non-Pacing GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the impact of different pacing rates on cardiac index measured by Swan-Ganz catheter in the postoperative period following cardiac surgery under cardiopulmonary bypass at H0, H6, H12, and H24.

To evaluate the impact of different pacing rates (50-69 bpm \[Category 1\], 70-79 bpm \[Category 2\], 80-89 bpm \[Category 3\], ≥ 90 bpm \[Category 4\]) on cardiac index measured by Swan-Ganz catheter in the postoperative period following cardiac surgery under cardiopulmonary bypass (CPB), at H0, H6, H12, and H24.

Time frame
24 hours after the surgery

Secondary outcomes

1

To determine whether atrial pacing reduces the incidence of atrial fibrillation in the pacing group compared to the non-pacing group in the postoperative period after cardiac surgery under CPB

Time frame
24 hours after the surgery
2

To evaluate the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on cardiac index measured by Swan-Ganz catheter in patients with heart failure following cardiac surgery under CPB

Time frame
24 hours after the surgery
3

To assess the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on mean arterial pressure in the postoperative period after cardiac surgery under CPB

Time frame
24 hours after the surgery
4

To evaluate the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on systemic vascular resistance measured by Swan-Ganz catheter in the postoperative period after cardiac surgery under CPB

Time frame
24 hours after the surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saint-Joseph University

Lead sponsor

Source ClinicalTrials.gov
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