Augmented Pacing for Shock in the Cardiac Intensive Care Unit

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Bradycardia; Shock; Cardiogenic Shock

Treatments: Device: Backup Pacing Rate Change

Study type: Interventional

Funder types: Other

Identifiers

NCT06713668

241410

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Standard Pacing (75 bpm) then Augmented Pacing (100 bpm)

Other group

Description:

Backup pacing rate will be set to 75 bpm first then 100 bpm second

Treatment:

Device: Backup Pacing Rate Change

Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm)

Other group

Description:

Backup pacing rate will be set to 100 bpm first then 75 bpm second

Treatment:

Device: Backup Pacing Rate Change