Augmented Pacing for Shock in the Cardiac Intensive Care Unit

NCT ID: NCT06713668

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2027-04-22

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.

Conditions

Cardiogenic Shock; Bradycardia; Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: OTHER

Backup Pacing Rate Change

Intervention Type: DEVICE

Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A

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

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

Group Type: OTHER

Backup Pacing Rate Change

Intervention Type: DEVICE

Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A

Interventions

Backup Pacing Rate Change

Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JGarry

Cardiovascular Medicine Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonah D Garry, M.D

Role: CONTACT

jonah.garry@vumc.org

914-523-3933

Facility Contacts

Jonah D Garry, MD

Role: primary

jonah.garry@vumc.org

914-523-3933

Other Identifiers

241410

Identifier Type: -

Identifier Source: org_study_id