Postoperative Pacing for Cardiac Efficiency

NCT07852390 | Recruiting

• 1 other identifier: STUDY00001292
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Renal NIRS; Postoperative cardiac pacing; Pediatric cardiac surgery; Postoperative care; Atrial pacing; Pediatric cardiology

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (10)

• Change in Cerebral NIRS Across Three Pacing Conditions

  The time frame for the cerebral NIRS will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.

• Change Mean Arterial Pressure Across Three Pacing Conditions

  The time frame for the mean arterial pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.

• Change in Mean Arterial Oxygen Saturation Across Three Pacing Conditions

  The time frame for the mean arterial pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.

• Change in Central Venous Pressure Across Three Pacing Conditions

  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.

• Change in Mean Airway Pressure Across Three Pacing Conditions

  The time frame for the mean airway pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.

Study Arms (2)

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.

Other: Temporary Atrial Pacing

Group 2: +20 bpm, +10 bpm, no pacing

EXPERIMENTAL

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.

Other: Temporary Atrial Pacing

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.

Group 1: No pacing, +20 bpm, +10 bpm; Group 2: +20 bpm, +10 bpm, no pacing

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert G. Webster, MD, MPH: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (15)

• Kielbasa G, Jastrzebski M, Bednarek A, Kusiak A, Sondej T, Bednarski A, Ostrowska A, Zydzik L, Rajzer M, Vijayaraman P, Moskal P. Strength-duration curves for left bundle branch area pacing. Heart Rhythm. 2024 Nov;21(11):2262-2269. doi: 10.1016/j.hrthm.2024.05.026. Epub 2024 May 15.

  PMID: 38759916 BACKGROUND

• Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Vijayaraman P, Czarnecka D. His bundle has a shorter chronaxie than does the adjacent ventricular myocardium: Implications for pacemaker programming. Heart Rhythm. 2019 Dec;16(12):1808-1816. doi: 10.1016/j.hrthm.2019.06.001. Epub 2019 Jun 8.

  PMID: 31181375 BACKGROUND

• Coates S, Thwaites B. The strength-duration curve and its importance in pacing efficiency: a study of 325 pacing leads in 229 patients. Pacing Clin Electrophysiol. 2000 Aug;23(8):1273-7. doi: 10.1111/j.1540-8159.2000.tb00943.x.

  PMID: 10962751 BACKGROUND

• Barold SS, Winner JA. Techniques and significance of threshold measurement for cardiac pacing. Relationship to output circuit of cardiac pacemakers. Chest. 1976 Dec;70(6):760-6. doi: 10.1378/chest.70.6.760.

  PMID: 1001053 BACKGROUND

• Barold SS, Ong LS, Heinle RA. Stimulation and sensing thresholds for cardiac pacing: electrophysiologic and technical aspects. Prog Cardiovasc Dis. 1981 Jul-Aug;24(1):1-24. doi: 10.1016/0033-0620(81)90025-6. No abstract available.

  PMID: 7019961 BACKGROUND

• Gaies MG, Gurney JG, Yen AH, Napoli ML, Gajarski RJ, Ohye RG, Charpie JR, Hirsch JC. Vasoactive-inotropic score as a predictor of morbidity and mortality in infants after cardiopulmonary bypass. Pediatr Crit Care Med. 2010 Mar;11(2):234-8. doi: 10.1097/PCC.0b013e3181b806fc.

  PMID: 19794327 BACKGROUND

• Zaleski KL, Kussman BD. Near-Infrared Spectroscopy in Pediatric Congenital Heart Disease. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):489-500. doi: 10.1053/j.jvca.2019.08.048. Epub 2019 Sep 3.

  PMID: 31582201 BACKGROUND

• Owens GE, King K, Gurney JG, Charpie JR. Low renal oximetry correlates with acute kidney injury after infant cardiac surgery. Pediatr Cardiol. 2011 Feb;32(2):183-8. doi: 10.1007/s00246-010-9839-x. Epub 2010 Nov 19.

  PMID: 21085945 BACKGROUND

• Niezen CK, Modestini M, Massari D, Bos AF, Scheeren TWL, Struys MMRF, Vos JJ. Prognostic Value of Perioperative Near-Infrared Spectroscopy Monitoring for Postoperative Acute Kidney Injury in Pediatric Cardiac Surgery: A Systematic Review. Semin Cardiothorac Vasc Anesth. 2025 Sep;29(3):209-218. doi: 10.1177/10892532251316682. Epub 2025 Feb 10.

  PMID: 39928846 BACKGROUND

• Ergul Y, Unsal S, Ozyilmaz I, Ozturk E, Carus H, Guzeltas A. Electrocardiographic and electrophysiologic effects of dexmedetomidine on children. Pacing Clin Electrophysiol. 2015 Jun;38(6):682-7. doi: 10.1111/pace.12623. Epub 2015 Apr 11.

  PMID: 25753681 BACKGROUND

• Wang Q, Chen C, Wang L. Efficacy and safety of dexmedetomidine in maintaining hemodynamic stability in pediatric cardiac surgery: a systematic review and meta-analysis. J Pediatr (Rio J). 2022 Jan-Feb;98(1):15-25. doi: 10.1016/j.jped.2021.05.008. Epub 2021 Jul 9.

  PMID: 34252370 BACKGROUND

• Mendel B, Christianto C, Setiawan M, Prakoso R, Siagian SN. A Comparative Effectiveness Systematic Review and Meta-analysis of Drugs for the Prophylaxis of Junctional Ectopic Tachycardia. Curr Cardiol Rev. 2022;18(1):e030621193817. doi: 10.2174/1573403X17666210603113430.

  PMID: 34082685 BACKGROUND

• Loomba RS, Villarreal EG, Farias JS, Flores S, Wong J. Factors associated with renal oxygen extraction in mechanically ventilated children after the Norwood operation: insights from high fidelity haemodynamic data. Cardiol Young. 2024 May 24:1-6. doi: 10.1017/S1047951124025174. Online ahead of print.

  PMID: 38783789 BACKGROUND

• Chauhan M, Prentice E, Zidan M, Walters HL 3rd, Delius RE, Mastropietro CW. Necessity of temporary epicardial pacing wires after surgery for congenital heart disease. Ann Thorac Surg. 2014 Jun;97(6):2148-53. doi: 10.1016/j.athoracsur.2014.02.020. Epub 2014 Mar 28.

  PMID: 24681035 BACKGROUND

• Barker GM, Affolter J, Saenz J, Cox CS, Forbess JM, Scott WA, Zeltser I. Temporary atrial pacing for cardiac output after pediatric cardiac surgery. Pediatr Cardiol. 2013 Oct;34(7):1605-11. doi: 10.1007/s00246-013-0687-3. Epub 2013 Mar 16.

  PMID: 23503930 BACKGROUND

Study Officials

• Robert G Webster, MD, MPH

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert G Webster, MD, MPH

CONTACT

312-227-4397; RGWebster@luriechildrens.org

Jeff Hong, MD

CONTACT

312-227-2525; jehong@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Section Chief, Electrophysiology

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)