Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Cardiac Index by thermodilution
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Standard Pacing (75 bpm) then Augmented Pacing (100 bpm)
Backup pacing rate will be set to 75 bpm first then 100 bpm second
干预措施: Backup Pacing Rate Change (Device)
Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm)
Backup pacing rate will be set to 100 bpm first then 75 bpm second
干预措施: Backup Pacing Rate Change (Device)
结局指标
主要结局
Cardiac Index by thermodilution
时间窗: 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)
次要结局
- 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)
研究者
JGarry
Cardiovascular Medicine Research Fellow
Vanderbilt University Medical Center