Postoperative Pacing for Cardiac Efficiency

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Robert G. Webster, MD, MPH
Study ID
NCT07852390
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Pacing
  • Pacing Therapy
  • Pediatric Congenital Heart Surgery
  • Postoperative Cardiac Surgery
  • Postoperative Care

Eligibility Criteria

Sex
ALL
Age
N/A - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Temporary Atrial Pacing — OTHER
    Temporary atrial pacing is delivered using temporary epicardial atrial pacing wires placed during cardiac surgery. During the protocol-directed pacing period, participants receive atrial pacing at either 10 or 20 beats per minute above their intrinsic sinus heart rate, according to their randomly assigned sequence. Each pacing condition is maintained for approximately three hours. The comparison condition is intrinsic sinus rhythm without protocol-directed atrial pacing. The protocol-directed pacing period occurs during approximately the first 10 postoperative hours. Pacing may be temporarily interrupted, skipped, or discontinued at the discretion of the treating clinical team when clinically indicated.

Study Details

The goal of this study is to determine whether temporarily increasing a child's heart rate after heart surgery can improve blood flow and oxygen supply to the body's tissues. The study will compare temporary atrial pacing at 10 and 20 beats per minute above the child's natural heart rate with the child's natural heart rate without pacing. Participants will be randomly assigned to one of two schedules for these pacing approaches. Each pacing approach has previously been used as part of routine care after heart surgery. The study will test whether temporarily increasing the heart rate improves blood flow and oxygen supply during the first 10 hours after surgery.

Key Dates

First listed
Oct 1, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: No pacing, +20 bpm, +10 bpm
    Participants first undergo intrinsic sinus rhythm without protocol-directed atrial pacing, followed by temporary atrial pacing at 20 beats per minute above the intrinsic sinus rate and then 10 beats per minute above the intrinsic sinus rate. Each condition is maintained for approximately three hours.
  • Experimental: Group 2: +20 bpm, +10 bpm, no pacing
    Participants first undergo temporary atrial pacing at 20 beats per minute above the intrinsic sinus rate, followed by atrial pacing at 10 beats per minute above the intrinsic sinus rate and then intrinsic sinus rhythm without protocol-directed atrial pacing. Each condition is maintained for approximately three hours.

Primary Outcome Measure

Change in Mean Renal Near-Infrared Spectroscopy (NIRS) Across Three Pacing Conditions [ Time Frame: The time frame for the mean renal NIRS will be during the final 30 minutes of each of the approximately 3-hour pacing conditions. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Robert G Webster, MD, MPH
[email protected]
312-227-4397
Halley V. Dillenbeck, BArch
[email protected]
312-227-4109
Robert G Webster, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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