Beat-to-beat Evaluation of Atrial Pacing to Test Fluid Responsiveness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Pacing protocol via routinely placed surgical pacemaker wire
Procedure/SurgeryA pacemaker wire is routinely placed by the cardiac surgeon after the surgery, as part of the standard care that occurs with every surgery. As part of the study protocol, an atrial pacing protocol is performed, starting with pacing at 80 bpm, then increasing by 10 beats per minute until reaching 120 bpm, followed by a gradual decrease back to 80 bpm. This protocol is repeated after the administration of the 500 mL fluid bolus. Additionally: As part of routine care, the intensivist frequently adjusts the pacemaker in this manner to test its function.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Standard atrial pacing (80-120 bpm) before and after a routine 500 mL fluid bolus.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
change in stroke volume measured before and after fluid administration in response to beat-to-beat atrial pacing.
The main study parameter is the change in stroke volume measured before and after fluid administration in response to beat-to-beat atrial pacing. Stroke volume will be assessed using VTI of the LVOT via transthoracic echocardiography. This change will be compared between fluid responders (defined as a ≥10% increase in stroke volume following fluid administration) and non-responders to assess the predictive accuracy of the pacing protocol.
Time frame
On day 1Secondary outcomes
1
Arterial wave form analysis (via intra-arterial blood pressure monitoring) to compare the ability of wave form analysis to detect stroke volume changes.
Arterial wave form analysis (via intra-arterial blood pressure monitoring) to compare the ability of wave form analysis to detect stroke volume changes.
Time frame
On day 12
Complementation of the clinical findings with computer simulations (CircAdapt) in a comparable virtual cohort of patients
Complementation of the clinical findings with computer simulations (CircAdapt) in a comparable virtual cohort of patients
Time frame
On day 1Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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