Increasing backup pacing rates for patients with cardiogenic shock
Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial
This study tests if raising the backup pacing rate to 100 beats per minute helps improve heart function in adults with slow heart rates and cardiogenic shock who are already in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06713668 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether increasing the backup pacing rate to 100 beats per minute improves hemodynamics in adults with relative bradycardia and cardiogenic shock. Participants, who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker, will be randomly assigned to experience two different pacing rates: 100 bpm and 75 bpm. Hemodynamic assessments will be conducted after 10 minutes at each pacing rate to determine the impact on cardiac index.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a permanent pacemaker, located in the CVICU, and experiencing relative bradycardia.
Not a fit: Patients with single chamber ICDs, those in sinus rhythm with leadless pacemakers, or those experiencing recent hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cardiac function and stability in patients experiencing cardiogenic shock.
How similar studies have performed: While this approach is novel, similar pacing interventions have shown promise in improving outcomes in patients with bradycardia and shock.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Jonah D Garry, M.D
- Email: jonah.garry@vumc.org
- Phone: 914-523-3933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.