๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.