The ICU-Resuscitation Project (ICU-RESUS)

NCT02837497 | Completed DMC

• 3 other identifiers: 15-012576R01HL131544UG1HD063108
• Study Type: interventional
• Target: 1,127
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric cardiac arrest affects thousands of hospitalized children each year. High quality cardiopulmonary resuscitation (CPR) saves lives, but is difficult to achieve. The objective of this study is to determine if a novel patient-centric resuscitation care improvement bundle consisting of bedside CPR training and multidisciplinary reviews of each cardiac arrest improves CPR quality and survival outcomes in a multi-center trial.

Conditions

Cardiac Arrest

Keywords

pediatric; heart arrest

Outcome Measures

Primary Outcomes (1)

• Good neurological survival

  Pediatric cerebral performance category of less than or equal to 3 or no change from baseline.

  Baseline and hospital discharge

Secondary Outcomes (1)

• Excellent CPR

  During cardiopulmonary resuscitation

Study Arms (2)

Control

NO INTERVENTION

Standard ICU resuscitation practices

ICU-RESUS CPR Improvement Bundle

EXPERIMENTAL

ICU-RESUS bundle implementation: 1) point-of-care bedside CPR training; and 2) post-cardiac arrest debriefings.

Other: ICU-RESUS CPR Improvement Bundle

Interventions

ICU-RESUS CPR Improvement Bundle OTHER

1. Point-of-care CPR training 2. Post-cardiac arrest educational debriefings

Also known as: ICU-RESUS

ICU-RESUS CPR Improvement Bundle

Eligibility Criteria

• Age: 37 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age greater than or equal to 37 weeks and less than or equal to18 years of age;
• AND Received CPR in the ICU setting

You may not qualify if:

• Pre-existing terminal illness and patient not expected to survive to hospital discharge.
• Lack of commitment to aggressive ICU therapies.
• Brain death determination prior to CPR event.
• First CPR event associated with this hospital admission was an out-of-hospital CPR event.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Utah: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (19)

• Berg RA, Nadkarni VM, Clark AE, Moler F, Meert K, Harrison RE, Newth CJ, Sutton RM, Wessel DL, Berger JT, Carcillo J, Dalton H, Heidemann S, Shanley TP, Zuppa AF, Doctor A, Tamburro RF, Jenkins TL, Dean JM, Holubkov R, Pollack MM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Incidence and Outcomes of Cardiopulmonary Resuscitation in PICUs. Crit Care Med. 2016 Apr;44(4):798-808. doi: 10.1097/CCM.0000000000001484.

  PMID: 26646466 BACKGROUND

• Wolfe H, Maltese MR, Niles DE, Fischman E, Legkobitova V, Leffelman J, Berg RA, Nadkarni VM, Sutton RM. Blood Pressure Directed Booster Trainings Improve Intensive Care Unit Provider Retention of Excellent Cardiopulmonary Resuscitation Skills. Pediatr Emerg Care. 2015 Nov;31(11):743-7. doi: 10.1097/PEC.0000000000000394.

  PMID: 25822236 BACKGROUND

• Sutton RM, Friess SH, Naim MY, Lampe JW, Bratinov G, Weiland TR 3rd, Garuccio M, Nadkarni VM, Becker LB, Berg RA. Patient-centric blood pressure-targeted cardiopulmonary resuscitation improves survival from cardiac arrest. Am J Respir Crit Care Med. 2014 Dec 1;190(11):1255-62. doi: 10.1164/rccm.201407-1343OC.

  PMID: 25321490 BACKGROUND

• Sutton RM, French B, Niles DE, Donoghue A, Topjian AA, Nishisaki A, Leffelman J, Wolfe H, Berg RA, Nadkarni VM, Meaney PA. 2010 American Heart Association recommended compression depths during pediatric in-hospital resuscitations are associated with survival. Resuscitation. 2014 Sep;85(9):1179-84. doi: 10.1016/j.resuscitation.2014.05.007. Epub 2014 May 16.

  PMID: 24842846 BACKGROUND

• Wolfe H, Zebuhr C, Topjian AA, Nishisaki A, Niles DE, Meaney PA, Boyle L, Giordano RT, Davis D, Priestley M, Apkon M, Berg RA, Nadkarni VM, Sutton RM. Interdisciplinary ICU cardiac arrest debriefing improves survival outcomes*. Crit Care Med. 2014 Jul;42(7):1688-95. doi: 10.1097/CCM.0000000000000327.

  PMID: 24717462 BACKGROUND

• Topjian AA, French B, Sutton RM, Conlon T, Nadkarni VM, Moler FW, Dean JM, Berg RA. Early postresuscitation hypotension is associated with increased mortality following pediatric cardiac arrest. Crit Care Med. 2014 Jun;42(6):1518-23. doi: 10.1097/CCM.0000000000000216.

  PMID: 24561563 BACKGROUND

• Ullman NL, Reeder RW, Topjian A, Morgan RW, Berg RA, Nadkarni VM, Palmer CA, Sutton RM, Press CA, Kirschen MP; ICU-RESUS, CPCCRN Investigators. Severe intracranial hemorrhage or ischemia associated with unfavorable outcomes after pediatric in-hospital cardiac arrest. Resuscitation. 2026 Jan;218:110886. doi: 10.1016/j.resuscitation.2025.110886. Epub 2025 Nov 7.

  PMID: 41207462 DERIVED

• Morgan RW, Reeder RW, Carcillo JA, Carpenter TC, Fitzgerald JC, Graham K, Kilbaugh TJ, Meert KL, Nadkarni VM, Palmer CA, Sharron MP, Weiss SL, Wolfe HA, Ahmed T, Bell MJ, Bishop R, Burns C, Diddle JW, Fink EL, Franzon D, Frazier AH, Friess SH, Hehir DA, Horvat CM, Huard LL, Maa T, McQuillen PS, Mourani PM, Naim MY, Pollack MM, Sapru A, Srivastava N, Yates AR, Berg RA, Sutton RM; for the ICU-Resuscitation Project (ICU-RESUS) Investigators and the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network Investigators. Outcomes, Characteristics, and Physiology of In-Hospital Cardiac Arrest in Children With Sepsis. Crit Care Med. 2025 Aug 1;53(8):e1529-e1541. doi: 10.1097/CCM.0000000000006739. Epub 2025 Jun 25.

  PMID: 40558671 DERIVED

• Siems A, Naim MY, Berg RA, Reeder RW, Ahmed T, Bell MJ, Bishop R, Bochkoris M, Burns C, Carcillo JA, Carpenter TC, Diddle JW, Federman M, Fernandez R, Fink EL, Franzon D, Frazier AH, Friess SH, Graham K, Hall M, Harding ML, Hehir DA, Horvat CM, Huard LL, Kilbaugh TJ, Maa T, Manga A, McQuillen PS, Meert KL, Mourani PM, Nadkarni VM, Notterman D, Pollack MM, Qunibi DW, Sapru A, Schneiter C, Sharron MP, Srivastava N, Tabbutt S, Tilford B, Viteri S, Wessel D, Wolfe HA, Yates AR, Zuppa AF, Morgan RW, Sutton RM. Association of Early Epinephrine with Hemodynamics and Outcome in Pediatric In-Hospital Cardiac Arrest: A Secondary Analysis of a Multicenter, Cluster-randomized Clinical Trial Intensive Care Unit Resuscitation (ICU-RESUS). Ann Am Thorac Soc. 2025 Sep;22(9):1361-1371. doi: 10.1513/AnnalsATS.202408-825OC.

  PMID: 40466056 DERIVED

• Kirschen MP, Ullman NL, Reeder RW, Ahmed T, Bell MJ, Berg RA, Burns C, Carcillo JA, Carpenter TC, Wesley Diddle J, Federman M, Fink EL, Frazier AH, Friess SH, Graham K, Horvat CM, Huard LL, Kilbaugh TJ, Maa T, Manga A, McQuillen PS, Meert KL, Morgan RW, Mourani PM, Nadkarni VM, Naim MY, Notterman D, Palmer CA, Pollack MM, Sapru A, Sharron MP, Srivastava N, Tilford B, Viteri S, Wolfe HA, Yates AR, Topjian A, Sutton RM, Press CA. Practice patterns for acquiring neuroimaging after pediatric in-hospital cardiac arrest. Resuscitation. 2025 Feb;207:110506. doi: 10.1016/j.resuscitation.2025.110506. Epub 2025 Jan 21.

  PMID: 39848427 DERIVED

• Nishisaki A, Reeder RW, McGovern EL, Ahmed T, Bell MJ, Bishop R, Bochkoris M, Burns C, Carcillo JA, Carpenter TC, Diddle W, Federman M, Fink EL, Franzon D, Frazier AH, Friess SH, Graham K, Hall M, Hehir DA, Horvat CM, Huard LL, Maa T, Manga A, McQuillen P, Meert KL, Morgan RW, Mourani PM, Nadkarni VM, Naim MY, Notterman D, Palmer CA, Sapru A, Schneiter C, Sharron MP, Srivastava N, Viteri S, Wessel D, Wolfe HA, Yates AR, Zuppa AF, Sutton RM, Berg RA. Brief report: incidence and outcomes of pediatric tracheal intubation-associated cardiac arrests in the ICU-RESUS clinical trial. Crit Care. 2024 Aug 30;28(1):286. doi: 10.1186/s13054-024-05065-0.

  PMID: 39215367 DERIVED

• Yates AR, Naim MY, Reeder RW, Ahmed T, Banks RK, Bell MJ, Berg RA, Bishop R, Bochkoris M, Burns C, Carcillo JA, Carpenter TC, Dean JM, Diddle JW, Federman M, Fernandez R, Fink EL, Franzon D, Frazier AH, Friess SH, Graham K, Hall M, Hehir DA, Horvat CM, Huard LL, Maa T, Manga A, McQuillen PS, Morgan RW, Mourani PM, Nadkarni VM, Notterman D, Pollack MM, Sapru A, Schneiter C, Sharron MP, Srivastava N, Tilford B, Viteri S, Wessel D, Wolfe HA, Yeh J, Zuppa AF, Sutton RM, Meert KL. Early Cardiac Arrest Hemodynamics, End-Tidal C o2 , and Outcome in Pediatric Extracorporeal Cardiopulmonary Resuscitation: Secondary Analysis of the ICU-RESUScitation Project Dataset (2016-2021). Pediatr Crit Care Med. 2024 Apr 1;25(4):312-322. doi: 10.1097/PCC.0000000000003423. Epub 2023 Dec 13.

  PMID: 38088765 DERIVED

• Morgan RW, Reeder RW, Bender D, Cooper KK, Friess SH, Graham K, Meert KL, Mourani PM, Murray R, Nadkarni VM, Nataraj C, Palmer CA, Srivastava N, Tilford B, Wolfe HA, Yates AR, Berg RA, Sutton RM; ICU-RESUS and Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN) Investigator Groups. Associations Between End-Tidal Carbon Dioxide During Pediatric Cardiopulmonary Resuscitation, Cardiopulmonary Resuscitation Quality, and Survival. Circulation. 2024 Jan 30;149(5):367-378. doi: 10.1161/CIRCULATIONAHA.123.066659. Epub 2023 Nov 6.

  PMID: 37929615 DERIVED

• Gardner MM, Hehir DA, Reeder RW, Ahmed T, Bell MJ, Berg RA, Bishop R, Bochkoris M, Burns C, Carcillo JA, Carpenter TC, Dean JM, Diddle JW, Federman M, Fernandez R, Fink EL, Franzon D, Frazier AH, Friess SH, Graham K, Hall M, Harding ML, Horvat CM, Huard LL, Maa T, Manga A, McQuillen PS, Meert KL, Morgan RW, Mourani PM, Nadkarni VM, Naim MY, Notterman D, Pollack MM, Sapru A, Schneiter C, Sharron MP, Srivastava N, Tilford B, Viteri S, Wessel D, Wolfe HA, Yates AR, Zuppa AF, Sutton RM, Topjian AA. Identification of post-cardiac arrest blood pressure thresholds associated with outcomes in children: an ICU-Resuscitation study. Crit Care. 2023 Oct 7;27(1):388. doi: 10.1186/s13054-023-04662-9.

  PMID: 37805481 DERIVED

• Federman M, Sutton RM, Reeder RW, Ahmed T, Bell MJ, Berg RA, Bishop R, Bochkoris M, Burns C, Carcillo JA, Carpenter TC, Dean JM, Diddle JW, Fernandez R, Fink EL, Franzon D, Frazier AH, Friess SH, Graham K, Hall M, Hehir DA, Horvat CM, Huard LL, Kirkpatrick T, Maa T, Maitoza LA, Manga A, McQuillen PS, Meert KL, Morgan RW, Mourani PM, Nadkarni VM, Notterman D, Palmer CA, Pollack MM, Sapru A, Schneiter C, Sharron MP, Srivastava N, Tilford B, Viteri S, Wessel D, Wolfe HA, Yates AR, Zuppa AF, Naim MY. Survival With Favorable Neurologic Outcome and Quality of Cardiopulmonary Resuscitation Following In-Hospital Cardiac Arrest in Children With Cardiac Disease Compared With Noncardiac Disease. Pediatr Crit Care Med. 2024 Jan 1;25(1):4-14. doi: 10.1097/PCC.0000000000003368. Epub 2023 Sep 7.

  PMID: 37678381 DERIVED

• Morgan RW, Reeder RW, Ahmed T, Bell MJ, Berger JT, Bishop R, Bochkoris M, Burns C, Carcillo JA, Carpenter TC, Dean JM, Diddle JW, Federman M, Fernandez R, Fink EL, Franzon D, Frazier AH, Friess SH, Graham K, Hall M, Hehir DA, Himebauch AS, Horvat CM, Huard LL, Maa T, Manga A, McQuillen PS, Meert KL, Mourani PM, Nadkarni VM, Naim MY, Notterman D, Page K, Pollack MM, Sapru A, Schneiter C, Sharron MP, Srivastava N, Tabbutt S, Tilford B, Viteri S, Wessel D, Wolfe HA, Yates AR, Zuppa AF, Berg RA, Sutton RM. Outcomes and characteristics of cardiac arrest in children with pulmonary hypertension: A secondary analysis of the ICU-RESUS clinical trial. Resuscitation. 2023 Sep;190:109897. doi: 10.1016/j.resuscitation.2023.109897. Epub 2023 Jul 3.

  PMID: 37406760 DERIVED

• Cashen K, Reeder RW, Ahmed T, Bell MJ, Berg RA, Burns C, Carcillo JA, Carpenter TC, Dean JM, Diddle JW, Federman M, Fink EL, Frazier AH, Friess SH, Graham K, Hall M, Hehir DA, Horvat CM, Huard LL, Maa T, Manga A, McQuillen PS, Morgan RW, Mourani PM, Nadkarni VM, Naim MY, Notterman D, Palmer CA, Pollack MM, Schneiter C, Sharron MP, Srivastava N, Wessel D, Wolfe HA, Yates AR, Zuppa AF, Sutton RM, Meert KL; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN) and National Heart Lung and Blood Institute ICU-RESUScitation Project Investigators. Sodium Bicarbonate Use During Pediatric Cardiopulmonary Resuscitation: A Secondary Analysis of the ICU-RESUScitation Project Trial. Pediatr Crit Care Med. 2022 Oct 1;23(10):784-792. doi: 10.1097/PCC.0000000000003045. Epub 2022 Jul 26.

  PMID: 35880872 DERIVED

• ICU-RESUS and Eunice Kennedy Shriver National Institute of Child Health; Human Development Collaborative Pediatric Critical Care Research Network Investigator Groups; Sutton RM, Wolfe HA, Reeder RW, Ahmed T, Bishop R, Bochkoris M, Burns C, Diddle JW, Federman M, Fernandez R, Franzon D, Frazier AH, Friess SH, Graham K, Hehir D, Horvat CM, Huard LL, Landis WP, Maa T, Manga A, Morgan RW, Nadkarni VM, Naim MY, Palmer CA, Schneiter C, Sharron MP, Siems A, Srivastava N, Tabbutt S, Tilford B, Viteri S, Berg RA, Bell MJ, Carcillo JA, Carpenter TC, Dean JM, Fink EL, Hall M, McQuillen PS, Meert KL, Mourani PM, Notterman D, Pollack MM, Sapru A, Wessel D, Yates AR, Zuppa AF. Effect of Physiologic Point-of-Care Cardiopulmonary Resuscitation Training on Survival With Favorable Neurologic Outcome in Cardiac Arrest in Pediatric ICUs: A Randomized Clinical Trial. JAMA. 2022 Mar 8;327(10):934-945. doi: 10.1001/jama.2022.1738.

  PMID: 35258533 DERIVED

• Reeder RW, Girling A, Wolfe H, Holubkov R, Berg RA, Naim MY, Meert KL, Tilford B, Carcillo JA, Hamilton M, Bochkoris M, Hall M, Maa T, Yates AR, Sapru A, Kelly R, Federman M, Michael Dean J, McQuillen PS, Franzon D, Pollack MM, Siems A, Diddle J, Wessel DL, Mourani PM, Zebuhr C, Bishop R, Friess S, Burns C, Viteri S, Hehir DA, Whitney Coleman R, Jenkins TL, Notterman DA, Tamburro RF, Sutton RM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN). Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial. Trials. 2018 Apr 3;19(1):213. doi: 10.1186/s13063-018-2590-y.

  PMID: 29615134 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Robert Sutton, MD MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 19, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

US (1)