Augmented Pacing for Shock in the Cardiac Intensive Care Unit
Purpose
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.
Conditions
- Cardiogenic Shock
- Bradycardia
- Shock
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center