Augmented Pacing for Shock in the Cardiac Intensive Care Unit

NCT06713668 | Active Not Recruiting FDA Device

• 1 other identifier: 241410
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiogenic Shock; Bradycardia; Shock; Pacing

Outcome Measures

Primary Outcomes (1)

• Cardiac Index by thermodilution

  Cardiac Index measured by thermodilution (in liters per minute per meters squared)

  At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes)

Secondary Outcomes (18)

• Cardiac Index by Indirect Fick

  0, 15, 30 minutes.

• Cardiac Output by thermodilution

  0, 15, 30 minutes.

• Cardiac Output by indirect fick

  0 ,15, 30 minutes

• Central Venous Pressure

  0, 15, 30 minutes

• Pulmonary Artery Systolic Pressure

  0, 15, 30 minutes

Study Arms (2)

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

OTHER

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

Device: Backup Pacing Rate Change

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

OTHER

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

Device: Backup Pacing Rate Change

Interventions

Backup Pacing Rate Change 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); Standard Pacing (75 bpm) then Augmented Pacing (100 bpm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Bradycardia; Shock

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Medicine Research Fellow

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: December 3, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 22, 2027
• Study Completion (Estimated): April 22, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)