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Recruiting NCT06713668

NCT06713668 Augmented Pacing for Shock in the Cardiac Intensive Care Unit

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Clinical Trial Summary
NCT ID NCT06713668
Status Recruiting
Phase
Sponsor Vanderbilt University Medical Center
Condition Cardiogenic Shock
Study Type INTERVENTIONAL
Enrollment 25 participants
Start Date 2025-04-22
Primary Completion 2027-04-22

Trial Parameters

Condition Cardiogenic Shock
Sponsor Vanderbilt University Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 25
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-22
Completion 2027-04-22
Interventions
Backup Pacing Rate Change

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Brief Summary

The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is: Does increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute Participants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate.

Eligibility Criteria

Inclusion Criteria: * Adults (age 18 and older) * Located in the CVICU * FDA approved permanent pacemaker in place (inclusive of dual-chamber and Bi-Ventricular ICDs) with labeling that allows backup pacing setting at 100 bpm. * Receiving a vasopressor or Inotrope for at least 4 hours * Average HR ≤ 75 bpm over the last hour (on Telemetry review) * Pulmonary artery catheter in place with functioning thermistor and pulmonary artery port. Exclusion Criteria: * Single chamber Implantable Cardiac Defibrillator * Sinus rhythm with a leadless pacemaker * Ventricular Tachycardia or Ventricular Fibrillation arrest in last 48 hours * Hemodynamic instability within the last 4 hours, defined as an increase in the dose of norepinephrine \> 10 mcg/min, an increase of epinephrine \> 10 mcg/kg/min, or initiation of a second vasopressor * Alternative indication for pacing rate change (i.e Torsade de Pointes, Recurrent Ventricular Tachycardia) * Comfort-focused care or anticipated death within 24 hours

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