Department of Anesthesia and Critical Care, Hôtel-Dieu de France Hospital
Beirut, Lebanon
Location status: Recruiting
NCT Number: NCT07082283
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?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beirut, Lebanon
Location status: Recruiting
Cardiac surgery under cardiopulmonary bypass (CPB) frequently leads to immediate postoperative rhythm or conduction disturbances, especially atrial fibrillation or atrioventricular block (AV Block), along with hemodynamic instability and transient reduction in cardiac output due to myocardial contractility impairment.
Temporary pacing wires are placed in the operating room and have been used since the 1960s to manage cardiac conduction disorders in these patients, allowing for atrial (AAI) or dual-chamber (DDD) pacing if necessary. Atrial pacing, by restoring synchronized atrial contraction with ventricular filling, helps maintain optimal cardiac output.
Cardiac output is defined as the product of heart rate (HR) and stroke volume (SV). To optimize cardiac output, increasing heart rate is possible, hence the need for atrial pacing.
A pacing rate slightly higher than spontaneous sinus rhythm appears to prevent pauses, limit rhythm instability, and reduce the risk of atrial fibrillation. However, the optimal pacing rate postoperatively has not been clearly defined, and data comparing different rates (70, 80, or 90 bpm) are scarce.
In our center, postoperative atrial pacing is nearly routine and commonly set at 90 bpm, a rate we consider optimal due to its alignment with the Frank-Starling curve. This rate maximizes venous return and stroke volume, thereby optimizing postoperative cardiac output.
Nevertheless, several studies have suggested that routine postoperative temporary pacing wire insertion may not always be necessary and should be reserved for patients identified as high-risk for postoperative rhythm disturbances.
Nowadays, in many international centers, the absence of routine temporary pacing has become the norm. Although 90 bpm is theoretically the optimal rate for atrial pacing, important questions remain: Is postoperative pacing absolutely necessary? If so, could a rate lower than 90 bpm suffice to maintain adequate hemodynamic profile (HDP)?
This study aims at determining whether routine temporary pacing is necessary during the first 24 hours after cardiac surgery under CPB, and what the optimal pacing rate is (AAI or DDD: 70 bpm vs. 80 bpm vs. 90 bpm) in terms of its impact on the HDP.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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:
Outside the pacing periods at different rates, patients in the non-pacing group will remain on their spontaneous sinus rhythm.
Time frame: 24 hours after the surgery
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
Time frame: 24 hours after the surgery
Time frame: 24 hours after the surgery
Time frame: 24 hours after the surgery
Time frame: 24 hours after the surgery
Time frame: 24 hours after the surgery
Interested in participating?
Request InfoSaint-Joseph University
Other
STAPH-CS Study: Short-Term Atrial Pacing and Hemodynamics After Cardiac Surgery - A Prospective Randomized Evaluation of Variable-Rate Atrial Stimulation After Cardiac Surgery With Cardiopulmonary Bypass
Acronym: STAPH-CS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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