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NCT Number: NCT06713668

Augmented Pacing for Shock in the Cardiac Intensive Care Unit

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Cardiac Index by thermodilution

    Time frame: 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 outcomes

  1. Cardiac Index by Indirect Fick

    Time frame: 0, 15, 30 minutes.

  2. Cardiac Output by thermodilution

    Time frame: 0, 15, 30 minutes.

  3. Cardiac Output by indirect fick

    Time frame: 0 ,15, 30 minutes

  4. Central Venous Pressure

    Time frame: 0, 15, 30 minutes

  5. Pulmonary Artery Systolic Pressure

    Time frame: 0, 15, 30 minutes

  6. Pulmonary Artery Diastolic Pressure

    Time frame: 0, 15, 30 minutes

  7. Pulmonary Artery Pulsitility Index

    Time frame: 0, 15, 30 minutes

  8. Right Ventricular Stroke Work Index

    Time frame: 0, 15, 30 minutes

  9. Pulmonary Artery (Mixed Venous) Blood Hemoglobin saturation

    Time frame: 0, 15, 30 minutes

  10. Cardiac Power Index (Thermodilution and indirect fick)

    Time frame: 0, 15, 30 minutes

  11. Cardiac Power Output (Thermodilution and indirect fick)

    Time frame: 0, 15, 30 minutes

  12. Systolic Blood pressure

    Time frame: 0, 15, 30 minutes

  13. Diastolic Blood Pressure

    Time frame: 0, 15, 30 minutes

  14. Mean Arterial Pressure

    Time frame: 0, 15, 30 minutes

  15. Difference in vasopressor/inotrope requirements

    Time frame: 0, 15, 30 minutes

  16. Arrhythmia events (Atrial and Ventricular)

    Time frame: 0, 15, 30 minutes

  17. Percentage of PVCs

    Time frame: 0, 15, 30 minutes

  18. Pacing percentage (Atrial, RV or Bi-V)

    Time frame: 0, 15, 30 minutes

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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