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.
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)
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)
Crossover
Temporary Atrial Pacing
Other interventionTemporary 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.
Change in Mean Renal Near-Infrared Spectroscopy (NIRS) Across Three Pacing Conditions
Renal near-infrared spectroscopy (NIRS) is a noninvasive monitor that estimates the amount of oxygen in blood within the tissues of the kidney. Renal NIRS will be continuously measured during each of the three study conditions: intrinsic sinus rhythm without protocol-directed pacing, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. The mean renal NIRS value during the final 30 minutes of each approximately 3-hour condition will be used for analysis. The primary outcome will assess the change in mean renal NIRS across the three pacing conditions, with each participant serving as their own control. Expected values for renal NIRS in post-operative cardiac surgery patients with congenital heart disease range from 45% to \> 95%.
Change in Cerebral NIRS Across Three Pacing Conditions
Cerebral near-infrared spectroscopy (NIRS) is a noninvasive monitor that estimates the amount of oxygen in blood within brain tissue. Cerebral NIRS will be measured during the three study conditions: intrinsic sinus rhythm without protocol-directed pacing, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Expected values for cerebral NIRS in post-operative cardiac surgery patients with congenital heart disease range from 45% to \> 95%.
Change Mean Arterial Pressure Across Three Pacing Conditions
Mean arterial pressure is an estimate of the average pressure in the arteries during a heartbeat and is routinely monitored after cardiac surgery. Mean arterial pressure will be recorded during the three study conditions. The mean value during the final 30 minutes of each approximately 3-hour condition will be compared across intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Expected ranges vary by age, sex and height (e.g., PMID: 28827377) and are adjusted for post-surgical status as opposed to ambulatory screening and management.
Change in Mean Arterial Oxygen Saturation Across Three Pacing Conditions
Arterial oxygen saturation is the percentage of hemoglobin in the blood that is carrying oxygen. It will be monitored during the three study conditions. The mean arterial oxygen saturation during the final 30 minutes of each approximately 3-hour condition will be compared across intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Expected values for mean arterial oxygen saturation in post-operative cardiac surgery patients with congenital heart disease range from 60% to \> 95%.
Change in Central Venous Pressure Across Three Pacing Conditions
Central venous pressure is the pressure measured in the central veins returning blood to the heart. Central venous pressure will be monitored as part of routine postoperative care. The mean central venous pressure during the final 30 minutes of each approximately 3-hour condition will be compared across intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Central venous pressure is highly dependent on the type of congenital heart disease repaired and will be compared to patients with similar physiology. Across a range of physiologic states, values are typically between 3 mmHg and 25 mmHg.
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Robert G. Webster, MD, MPH
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor institution
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborator
