Beat-to-beat Evaluation of Atrial Pacing to Test Fluid Responsiveness (NCT07730242) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Beat-to-beat Evaluation of Atrial Pacing to Test Fluid Responsiveness
18 participantsStarted 2027-01
Plain-language summary
The goal of this observational study is to learn whether atrial pacing-induced preload variation can identify fluid responsiveness in adult patients admitted to the intensive care unit after cardiac surgery.
The main questions it aims to answer are:
Can beat-to-beat atrial pacing induce measurable changes in stroke volume that predict fluid responsiveness? Do stroke volume changes measured by transthoracic echocardiography (LVOT VTI) and arterial waveform analysis identify patients who respond to a 500 mL fluid bolus?
Researchers will compare fluid responders and non-responders, defined by a ≥10% increase in stroke volume after a 500 mL Ringer's lactate fluid bolus, to determine whether pacing-induced hemodynamic changes predict fluid responsiveness.
Participants will:
Undergo a standardized atrial pacing protocol (80-120 bpm in 10 bpm increments) before and after a routine 500 mL Ringer's lactate fluid bolus.
Undergo transthoracic echocardiography and continuous arterial pressure monitoring during the pacing protocol.
Have routine ICU hemodynamic data collected during their admission.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or older.
* Underwent CABG surgery, without concomitant valve surgery.
* Admitted to the ICU during the first postoperative day.
* Equipped with surgically placed temporary atrial pacemaker wire.
* Scheduled for a 500 mL bolus of balanced solution (Ringer's lactate) within the first two postoperative hours for clinical reasons.
* Able to provide preoperative consent at the outpatient clinic before the surgery takes place.
* Assessed by the attending intensivist as hemodynamically stable and (thereby) eligible for the study.
Exclusion Criteria:
* Presence of atrial fibrillation or other arrhythmias precluding atrial pacing.
* Absence of atrial pacemaker wire.
* Suspected cardiac tamponade or significant postoperative bleeding (e.g., \>400 mL blood loss in the first hour postoperatively).
* Use of extracorporeal life support (ECLS) during the observation period.
* Acute changes in vasopressor or inotrope dosage within the observation period.
* Significant changes in body position, ventilator settings, or pacing mode during the study protocol.
* Known contraindications to echocardiographic monitoring or arterial wave form analysis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in stroke volume measured before and after fluid administration in response to beat-to-beat atrial pacing.