Image

Augmented Pacing for Shock in the Cardiac Intensive Care Unit

Augmented Pacing for Shock in the Cardiac Intensive Care Unit

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

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

Study details
    Cardiogenic Shock
    Bradycardia
    Shock

NCT06713668

Vanderbilt University Medical Center

13 May 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.