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Augmented Pacing for Shock in the Cardiac Intensive Care Unit

RECRUITINGN/ASponsored by Vanderbilt University Medical Center
Actively Recruiting
PhaseN/A
SponsorVanderbilt University Medical Center
Started2025-04-22
Est. completion2027-04-22
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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
* Mechanical circulatory support in place
* Newly discovered pacing system malfunction (lead displacement, loss of capture, elevated capture threshold, significant lead impedance change, battery depletion, undersensing or oversensing)
* Non-English Speaking

Conditions4

BradycardiaCardiogenic ShockHeart DiseaseShock

Locations1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jonah D Garry, MD914-523-3933jonah.garry@vumc.org

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