Clinical trial NCT06713668: Augmented Pacing for Shock in the Cardiac Intensive Care Unit
Official title: Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Bradycardia
Shock
Keywords: Cardiogenic Shock
Bradycardia
Shock
Pacing
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cardiac Index by thermodilution
timeFrame: At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes)
Secondary outcomes:
measure: Cardiac Index by Indirect Fick
timeFrame: 0, 15, 30 minutes.
measure: Cardiac Output by thermodilution
timeFrame: 0, 15, 30 minutes.
measure: Cardiac Output by indirect fick
timeFrame: 0 ,15, 30 minutes
measure: Central Venous Pressure
timeFrame: 0, 15, 30 minutes
measure: Pulmonary Artery Systolic Pressure
timeFrame: 0, 15, 30 minutes
measure: Pulmonary Artery Diastolic Pressure
timeFrame: 0, 15, 30 minutes
measure: Pulmonary Artery Pulsitility Index
timeFrame: 0, 15, 30 minutes
measure: Right Ventricular Stroke Work Index
timeFrame: 0, 15, 30 minutes
measure: Pulmonary Artery (Mixed Venous) Blood Hemoglobin saturation
timeFrame: 0, 15, 30 minutes
measure: Cardiac Power Index (Thermodilution and indirect fick)
timeFrame: 0, 15, 30 minutes
measure: Cardiac Power Output (Thermodilution and indirect fick)
timeFrame: 0, 15, 30 minutes
measure: Systolic Blood pressure
timeFrame: 0, 15, 30 minutes
measure: Diastolic Blood Pressure
timeFrame: 0, 15, 30 minutes
measure: Mean Arterial Pressure
timeFrame: 0, 15, 30 minutes
measure: Difference in vasopressor/inotrope requirements
timeFrame: 0, 15, 30 minutes
measure: Arrhythmia events (Atrial and Ventricular)
timeFrame: 0, 15, 30 minutes
measure: Percentage of PVCs
timeFrame: 0, 15, 30 minutes
measure: Pacing percentage (Atrial, RV or Bi-V)
timeFrame: 0, 15, 30 minutes
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: