RECRUITING

Augmented Pacing for Shock in the Cardiac Intensive Care Unit

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-22
Study Completion:2027-04-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06713668

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (age 18 and older)
  2. * Located in the CVICU
  3. * FDA approved permanent pacemaker in place (inclusive of dual-chamber and Bi-Ventricular ICDs) with labeling that allows backup pacing setting at 100 bpm.
  4. * Receiving a vasopressor or Inotrope for at least 4 hours
  5. * Average HR ≤ 75 bpm over the last hour (on Telemetry review)
  6. * Pulmonary artery catheter in place with functioning thermistor and pulmonary artery port.
  1. * Single chamber Implantable Cardiac Defibrillator
  2. * Sinus rhythm with a leadless pacemaker
  3. * Ventricular Tachycardia or Ventricular Fibrillation arrest in last 48 hours
  4. * 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
  5. * Alternative indication for pacing rate change (i.e Torsade de Pointes, Recurrent Ventricular Tachycardia)
  6. * Comfort-focused care or anticipated death within 24 hours
  7. * Mechanical circulatory support in place
  8. * Newly discovered pacing system malfunction (lead displacement, loss of capture, elevated capture threshold, significant lead impedance change, battery depletion, undersensing or oversensing)
  9. * Non-English Speaking

Contacts and Locations

Study Contact

Jonah D Garry, M.D
CONTACT
914-523-3933
jonah.garry@vumc.org

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-22
Study Completion Date2027-04-22

Study Record Updates

Study Start Date2025-04-22
Study Completion Date2027-04-22

Terms related to this study

Keywords Provided by Researchers

  • Cardiogenic Shock
  • Bradycardia
  • Shock
  • Pacing

Additional Relevant MeSH Terms

  • Cardiogenic Shock
  • Bradycardia
  • Shock