Augmented Pacing for Shock in the Cardiac Intensive Care Unit

Description

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

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Study Overview

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Study Details

Study overview

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.

Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial

Augmented Pacing for Shock in the Cardiac Intensive Care Unit

Condition
Cardiogenic Shock
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Study Record Dates

2027-04-22