- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02837497
The ICU-Resuscitation Project (ICU-RESUS) (ICU-RESUS)
Improving Outcomes After Pediatric Cardiac Arrest
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pediatric cardiac arrest affects thousands of hospitalized children each year. Progressive heart and lung failure is a predisposing cause in the majority of these events. While cardiac arrest survival outcomes have improved over the last decade, more than half of these children will not live to hospital discharge. As brain injury complicates care in those who do survive, the burden to these children and the public's health is substantial.
Cardiopulmonary resuscitation (CPR) - the medical procedure of providing chest compressions and ventilations during cardiac arrest - is life saving, and higher quality CPR is more effective at doing so. However, providing high quality care during the resuscitation of a child is difficult. Attempts to improve care through conventional training methods have not been successful; therefore, interventions to improve the quality of pediatric CPR and outcomes are needed.
The objective of this study is to determine if a novel resuscitation care improvement bundle that improved outcomes in a single center intensive care unit (ICU) efficacy study is generalizable to other pediatric institutions in a multi-center effectiveness trial. The ICU-Resuscitation (ICU-RESUS) bundle includes: 1) CPR training at the point-of-care (in the ICU rather than a classroom away from patients); and 2) interdisciplinary structured reviews of each cardiac arrest that emphasize patient-centric physiology intended to optimize intra-arrest and post-arrest care. The ICU-RESUS bundle substantially improved CPR quality and nearly doubled the number of children surviving their event during the single center efficacy trial. In this study, a multi-institutional parallel stepped-wedge hybrid cluster-randomized trial, which leverages the existing infrastructure of the National Institute of Child Health and Human Development (NICHD)-funded Collaborative Pediatric Critical Care Research Network (CPCCRN), is proposed with the following aims: 1) Evaluate the effectiveness of the ICU-RESUS interventional bundle to improve outcomes of children treated for an ICU cardiac arrest; and 2) Evaluate the effectiveness of the ICU-RESUS interventional bundle to improve the quality of CPR provided by ICU healthcare providers in the population of children treated for an ICU cardiac arrest.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age greater than or equal to 37 weeks and less than or equal to18 years of age;
- AND Received CPR in the ICU setting
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
Standard ICU resuscitation practices
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Experimental: ICU-RESUS CPR Improvement Bundle
ICU-RESUS bundle implementation: 1) point-of-care bedside CPR training; and 2) post-cardiac arrest debriefings.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Good neurological survival
Time Frame: Baseline and hospital discharge
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Pediatric cerebral performance category of less than or equal to 3 or no change from baseline.
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Baseline and hospital discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excellent CPR
Time Frame: During cardiopulmonary resuscitation
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A composite variable of systolic blood pressure >60 mmHg for neonates, >80 mmHg for infants, or >100 mmHg for older patients AND compression rate between 100-120 / minute, AND a chest compression fraction greater than or equal to 80%.
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During cardiopulmonary resuscitation
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Sutton, MD MSCE, Children's Hospital of Philadelphia
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-012576
- R01HL131544 (U.S. NIH Grant/Contract)
- UG1HD063108 (U.S. NIH Grant/Contract)
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