Augmented Pacing for Shock in the Cardiac Intensive Care Unit

Not Applicable

Recruiting

• Conditions: Cardiogenic Shock; Bradycardia; Shock

• Registration Number: NCT06713668
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Status Verified: 2025-04
• Study Start: 2025-04-22
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-04-22
• Study Completion: 2027-04-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cardiac Index by thermodilution	At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes)	Cardiac Index measured by thermodilution (in liters per minute per meters squared)

Secondary Outcome Measures

Name	Time	Method
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
Pulmonary Artery Diastolic Pressure	0, 15, 30 minutes
Pulmonary Artery Pulsitility Index	0, 15, 30 minutes
Right Ventricular Stroke Work Index	0, 15, 30 minutes
Pulmonary Artery (Mixed Venous) Blood Hemoglobin saturation	0, 15, 30 minutes
Cardiac Power Index (Thermodilution and indirect fick)	0, 15, 30 minutes
Cardiac Power Output (Thermodilution and indirect fick)	0, 15, 30 minutes
Systolic Blood pressure	0, 15, 30 minutes
Diastolic Blood Pressure	0, 15, 30 minutes
Mean Arterial Pressure	0, 15, 30 minutes
Difference in vasopressor/inotrope requirements	0, 15, 30 minutes
Arrhythmia events (Atrial and Ventricular)	0, 15, 30 minutes
Percentage of PVCs	0, 15, 30 minutes
Pacing percentage (Atrial, RV or Bi-V)	0, 15, 30 minutes

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States