Postoperative Atrial Pacing in Children After Heart Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial uses a randomized, within-subject design to compare three postoperative heart rate conditions in pediatric patients: intrinsic sinus rhythm, pacing at 10 bpm above the intrinsic rate, and pacing at 20 bpm above the intrinsic rate. Each condition is maintained for about three hours during the first 10 hours after surgery, with order determined by random sequencing. Participants are grouped by single-ventricle or two-ventricle physiology and serve as their own controls to assess physiologic responses. Continuous data from routine monitoring will be collected to characterize blood flow and tissue oxygenation, and a secondary component will evaluate the pacing wire thresholds from the first postoperative day through day 3.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age less than 12 years (all potential recruitment). Target recruitment will focus on children less than 12 months at enrollment. Children aged 13-36 months will be eligible for recruitment if we do not meet the target recruitment goals for infants according to the study timeline, and then all patients \< 12 years if recruitment is still below targets.
* Scheduled for congenital cardiac surgery at Lurie Children's Hospital
* Planned postoperative admission to the CICU
* Informed consent obtained from parent(s) or legally authorized representative(s)

Exclusion Criteria:

* Pregnant patient at time of surgery
* Category 2 and category 3 patients on the pulmonary artery reconstruction (PAR) program
* Junctional or ventricular rhythm at baseline
* Uncontrolled tachyarrhythmia (for example, but not limited to, atrial or ventricular tachycardia, atrioventricular re-entrant arrhythmias)
* Hemodynamically significant bleeding, defined as active bleeding that, in the judgment of the treating clinical team, requires ongoing blood product transfusion, surgical or catheter-based intervention, or results in hemodynamic instability requiring escalation of clinical support
* Postoperative cardiac arrest prior to protocol initiation or during the protocol period
* Requirement for mechanical circulatory support
* Requirement for ventricular pacing
* Arterial pH less than 7.10
* Determination by the treating clinical team that participation is not in the patient's best clinical interest

Where it's running

• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Robert G Webster, MD, MPH — Ann & Robert H Lurie Children's Hospital of Chicago
• Study coordinator: Robert G Webster, MD, MPH
• Email: RGWebster@luriechildrens.org
• Phone: 312-227-4397

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.