[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658522":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":61,"studyPopulation":53,"armGroups":62,"interventions":73,"overallOfficials":78,"centralContacts":82,"locations":91,"responsibleParty":114,"collaborators":118,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":53,"maxAge":128,"enrollmentInfo":129,"targetDuration":53,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":142,"overallStatus":94,"whyStopped":53,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"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%.","The time frame for the mean renal NIRS will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.",[14,18,22,25,29,33,37,41,45,49],{"measure":15,"description":16,"timeFrame":17},"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%.","The time frame for the cerebral NIRS will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.",{"measure":19,"description":20,"timeFrame":21},"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.","The time frame for the mean arterial pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.",{"measure":23,"description":24,"timeFrame":21},"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%.",{"measure":26,"description":27,"timeFrame":28},"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.","The time frame for the mean central venous pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.",{"measure":30,"description":31,"timeFrame":32},"Change in Mean Airway Pressure Across Three Pacing Conditions","Mean airway pressure is the average pressure in the airways during a respiratory cycle. It will be recorded when available as part of routine postoperative care. The mean airway 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. Normal values are between 5-10 cmH₂O for our participant population.","The time frame for the mean airway pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.",{"measure":34,"description":35,"timeFrame":36},"Change in Serum Lactate Concentration During the First 72 Hours After Surgery","Serum lactate concentration will be obtained from laboratory testing performed as part of routine postoperative clinical care. Lactate values and their corresponding collection times will be recorded and used to evaluate changes in lactate concentration following surgery and in relation to the study pacing conditions. No additional blood samples are required for the study. Expected values are lower than 10 mmol\u002FL for most patients during recovery, although higher values are possible during marginal physiologic states. There is no meaningful interpretation of a low lactate level during surgical recovery and a level below the threshold of assay detection will be interpreted as a normal value.","The time frame for the serum lactate concentration will be from initiation of the baseline observation period through 72 hours after CICU admission.",{"measure":38,"description":39,"timeFrame":40},"Change in Arterial pH During the First 72 Hours After Surgery","Arterial pH measures the acidity or alkalinity of arterial blood. Arterial pH values obtained from blood gas testing performed as part of routine postoperative clinical care will be recorded with their corresponding collection times. Changes in arterial pH will be evaluated during the postoperative period in relation to the study pacing conditions. No additional blood samples are required for the study. While physiologic values between 7.35 and 7.45 are target values, we anticipate that patients will transiently have values between 7.2 and 7.35. Values lower than 7.2 will be evaluated by our clinical team. It is unusual to have significant non-iatrogenic alkalosis in the post-surgical state.","The time frame for the arterial pH will be from initiation of the baseline observation period through 72 hours after CICU admission.",{"measure":42,"description":43,"timeFrame":44},"Change in Arterial Bicarbonate Concentration During the First 72 Hours After Surgery","Arterial bicarbonate concentration is a measure obtained from arterial blood gas testing that provides information about the body's acid-base balance. Bicarbonate values obtained as part of routine postoperative clinical care will be recorded with their corresponding collection times. Changes in arterial bicarbonate concentration will be evaluated during the postoperative period in relation to the study pacing conditions. No additional blood samples are required for the study. We expected values between 21-27 mmol\u002FL for our participant population.","The time frame for the arterial bicarbonate concentration will be from initiation of the baseline observation period through 72 hours after CICU admission.",{"measure":46,"description":47,"timeFrame":48},"Change in Intrinsic Heart Rate Across Three Pacing Conditions","Intrinsic heart rate is the participant's natural heart rate without protocol-directed atrial pacing. Heart rate will be continuously monitored during each study condition. Intrinsic heart rate measurements will be used to characterize the participant's underlying heart rate during the pacing phases and to evaluate changes associated with the different pacing conditions. Normal values are between 100-180 bpm for our participant population.","The time frame for the intrinsic heart rate will be during the final 15 minutes of each approximately 3-hour pacing conditions.",{"measure":50,"description":51,"timeFrame":52},"Pacing Capture Thresholds and Derived Rheobase and Chronaxie During the First 72 Hours After Surgery","Pacing capture thresholds are the minimum electrical stimulus strengths required to consistently capture the heart and will be measured across multiple pulse durations using temporary epicardial pacing wires and routine temporary pacing equipment. These measurements will be used to construct postoperative strength-duration curves and derive rheobase and chronaxie, which describe the electrical stimulus characteristics required for cardiac capture. Measurements will be obtained at baseline and daily through postoperative day 3 to evaluate changes in pacing requirements and electrophysiologic properties over the postoperative period.","The time line will be at baseline and postoperative days 1, 2, and 3.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":53,"timePerspective":53,"maskingInfo":59},"RANDOMIZED","CROSSOVER","Participants are divided into two prespecified physiologic groups based on single-ventricle versus two-ventricle circulation. Within each group, participants are randomized to one of two sequences of the same three study conditions: 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. Thus, all participants receive the same three conditions, but the order and timing of the conditions differ according to the assigned sequence, allowing each participant to serve as their own control.","TREATMENT",{"masking":60,"maskingDescription":53,"whoMasked":53},"NONE","This study uses a randomized, within-subject design to evaluate three postoperative heart rate conditions: intrinsic sinus rhythm, temporary atrial pacing at 10 beats per minute above the intrinsic sinus rate, and temporary atrial pacing at 20 beats per minute above the intrinsic sinus rate. Participants will be randomized to one of two sequences determining the order in which these conditions are administered. Each pacing condition will be maintained for approximately three hours during the early postoperative period.\n\nParticipants will be grouped according to single-ventricle or two-ventricle physiology. The study uses a within-subject design so that each participant serves as their own control when comparing physiologic responses to the three heart rate conditions.\n\nContinuous physiologic data will be collected during the postoperative study period using the institutional Sickbay physiologic data acquisition platform. Data obtained through routine postoperative monitoring will be used to characterize physiologic responses during and between pacing conditions. No additional physiologic monitoring devices or research-only laboratory testing are required.\n\nA secondary component of the study evaluates the electrophysiologic properties of temporary epicardial pacing wires during the postoperative period. We will measure how much electricity is required to pace the heart on the first day after surgery and daily through postoperative day 3. Threshold testing is performed using standard clinical pacing equipment and techniques and only when the treating clinical team determines that testing is clinically appropriate and safe.\n\nThe study is open-label; neither treating clinicians nor study personnel are blinded to pacing status or pacing rate. Study-specific procedures are limited to the postoperative hospitalization, with data collection continuing through the 3-day postoperative period. After completion or discontinuation of protocol-directed pacing, subsequent pacing and medical management are determined solely by the treating clinical team.",[63,69],{"label":64,"type":65,"description":66,"interventionNames":67},"Group 1: No pacing, +20 bpm, +10 bpm","EXPERIMENTAL","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.",[68],"Other: Temporary Atrial Pacing",{"label":70,"type":65,"description":71,"interventionNames":72},"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.",[68],[74],{"type":6,"name":75,"description":76,"armGroupLabels":77,"otherNames":53},"Temporary Atrial Pacing","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.",[64,70],[79],{"name":80,"affiliation":5,"role":81},"Robert G Webster, MD, MPH","PRINCIPAL_INVESTIGATOR",[83,87],{"name":80,"role":84,"phone":85,"phoneExt":53,"email":86},"CONTACT","312-227-4397","RGWebster@luriechildrens.org",{"name":88,"role":84,"phone":89,"phoneExt":53,"email":90},"Jeff Hong, MD","312-227-2525","jehong@luriechildrens.org",[92],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Ann & Robert H. Lurie Children's Hospital of Chicago","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-87.65005,41.85003,{"lat":104,"lon":103},[107,109,113],{"name":80,"role":84,"phone":85,"phoneExt":53,"email":108},"rgwebster@luriechildrens.org",{"name":110,"role":84,"phone":111,"phoneExt":53,"email":112},"Halley V. Dillenbeck, BArch","312-227-4109","hdillenbeck@luriechildrens.org",{"name":80,"role":81,"phone":53,"phoneExt":53,"email":53},{"type":115,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"SPONSOR_INVESTIGATOR","Robert G. Webster, MD, MPH","Section Chief, Electrophysiology",[119],{"name":5,"class":6},"100658522","postoperative-pacing-for-cardiac-efficiency-100658522",false,"NCT07852390","Postoperative Pacing for Cardiac Efficiency","POSTPACE","Inclusion Criteria:\n\n* 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 \\\u003C 12 years if recruitment is still below targets.\n* Scheduled for congenital cardiac surgery at Lurie Children's Hospital\n* Planned postoperative admission to the CICU\n* Informed consent obtained from parent(s) or legally authorized representative(s)\n\nExclusion Criteria:\n\n* Pregnant patient at time of surgery\n* Category 2 and category 3 patients on the pulmonary artery reconstruction (PAR) program\n* Junctional or ventricular rhythm at baseline\n* Uncontrolled tachyarrhythmia (for example, but not limited to, atrial or ventricular tachycardia, atrioventricular re-entrant arrhythmias)\n* 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\n* Postoperative cardiac arrest prior to protocol initiation or during the protocol period\n* Requirement for mechanical circulatory support\n* Requirement for ventricular pacing\n* Arterial pH less than 7.10\n* Determination by the treating clinical team that participation is not in the patient's best clinical interest","ALL","12 Years",{"count":130,"type":131},46,"ESTIMATED","INTERVENTIONAL",[134],"NA","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.\n\nParticipants 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.",[137,138,139,140,141],"Pacing Therapy","Postoperative Care","Pediatric Congenital Heart Surgery","Cardiac Pacing","Postoperative Cardiac Surgery",[143,144,145,146,147,148],"Renal NIRS","Postoperative cardiac pacing","Pediatric cardiac surgery","Postoperative care","Atrial pacing","Pediatric cardiology","2026-09-30",{"date":151,"type":152},"2026-10-01","ACTUAL",{"date":151,"type":131},{"date":155,"type":131},"2027-12-31",{"name":116,"class":6},1]