Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Jonah D Garry, M.D
jonah.garry@vumc.org
914-523-3933
Time Frame
Start Date: 2025-04-22
Estimated Completion Date: 2027-04-22
Participants
Target number of participants: 25
Treatments
Other: Standard Pacing (75 bpm) then Augmented Pacing (100 bpm)
Backup pacing rate will be set to 75 bpm first then 100 bpm second
Other: Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm)
Backup pacing rate will be set to 100 bpm first then 75 bpm second
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov