Augmented Pacing for Shock in the Cardiac Intensive Care Unit
Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Nov 27, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether increasing the backup pacing rate of a pacemaker can improve heart function in adults who have a condition called cardiogenic shock and experience a slower than normal heart rate (known as bradycardia). Specifically, the researchers want to find out if setting the pacemaker to 100 beats per minute instead of 75 beats per minute makes a difference in how well the heart pumps blood. Participants will already be in the Cardiovascular Intensive Care Unit (CVICU) and must have a permanent pacemaker and a special catheter in place to monitor their heart function.
To be eligible for this study, participants need to be adults aged 18 and older, have a functioning FDA-approved permanent pacemaker, and be receiving medication to support their heart function for at least four hours. They will undergo testing where they will experience both pacing rates, with heart function being monitored for 10 minutes at each rate. This trial is not yet recruiting participants, but it aims to learn more about how adjusting the pacing rate can help improve care for patients with serious heart conditions.
Gender
ALL
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
About Vanderbilt University Medical Center
Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported