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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Pacing (75 bpm) then Augmented Pacing (100 bpm) | Other | Backup pacing rate will be set to 75 bpm first then 100 bpm second |
|
| Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm) | Other | Backup pacing rate will be set to 100 bpm first then 75 bpm second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Backup Pacing Rate Change | Device | Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Index by thermodilution | Cardiac Index measured by thermodilution (in liters per minute per meters squared) | At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Index by Indirect Fick | 0, 15, 30 minutes. | |
| Cardiac Output by thermodilution | 0, 15, 30 minutes. | |
| Cardiac Output by indirect fick |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D001919 | Bradycardia |
| D012769 | Shock |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001145 | Arrhythmias, Cardiac |