Bradycardia, Cardiogenic Shock, Shock
Conditions
Keywords
Cardiogenic Shock, Bradycardia, Shock, Pacing
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.
Interventions
DEVICEBackup Pacing Rate Change
Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Index by thermodilution | At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes) | Cardiac Index measured by thermodilution (in liters per minute per meters squared) |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac Index by Indirect Fick | 0, 15, 30 minutes. |
| Cardiac Output by thermodilution | 0, 15, 30 minutes. |
| Cardiac Output by indirect fick | 0 ,15, 30 minutes |
| Central Venous Pressure | 0, 15, 30 minutes |
| Pulmonary Artery Systolic Pressure | 0, 15, 30 minutes |
| Pulmonary Artery Diastolic Pressure | 0, 15, 30 minutes |
| Pulmonary Artery Pulsitility Index | 0, 15, 30 minutes |
| Right Ventricular Stroke Work Index | 0, 15, 30 minutes |
| Pulmonary Artery (Mixed Venous) Blood Hemoglobin saturation | 0, 15, 30 minutes |
| Cardiac Power Index (Thermodilution and indirect fick) | 0, 15, 30 minutes |
| Cardiac Power Output (Thermodilution and indirect fick) | 0, 15, 30 minutes |
| Systolic Blood pressure | 0, 15, 30 minutes |
| Diastolic Blood Pressure | 0, 15, 30 minutes |
| Mean Arterial Pressure | 0, 15, 30 minutes |
| Difference in vasopressor/inotrope requirements | 0, 15, 30 minutes |
| Arrhythmia events (Atrial and Ventricular) | 0, 15, 30 minutes |
| Percentage of PVCs | 0, 15, 30 minutes |
| Pacing percentage (Atrial, RV or Bi-V) | 0, 15, 30 minutes |
Countries
United States
Outcome results
None listed