The ICU-Resuscitation Project (ICU-RESUS) (ICU-RESUS)

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ClinicalTrials.gov Identifier: NCT02837497

Recruitment Status : Recruiting

First Posted : July 19, 2016

Last Update Posted : December 24, 2019

See Contacts and Locations

Sponsor:

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

University of Utah

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Children's Hospital of Philadelphia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest	Other: ICU-RESUS CPR Improvement Bundle	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1540 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Improving Outcomes After Pediatric Cardiac Arrest
Study Start Date :	October 2016
Estimated Primary Completion Date :	March 2021
Estimated Study Completion Date :	March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control Standard ICU resuscitation practices
Experimental: ICU-RESUS CPR Improvement Bundle ICU-RESUS bundle implementation: 1) point-of-care bedside CPR training; and 2) post-cardiac arrest debriefings.	Other: ICU-RESUS CPR Improvement Bundle Point-of-care CPR training Post-cardiac arrest educational debriefings Other Name: ICU-RESUS

Outcome Measures

Primary Outcome Measures :

Good neurological survival [ Time Frame: Baseline and hospital discharge ]
Pediatric cerebral performance category of less than or equal to 3 or no change from baseline.

Secondary Outcome Measures :

Excellent CPR [ Time Frame: During cardiopulmonary resuscitation ]
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%.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	37 Weeks to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837497

Contacts

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Contact: Sharon Carbonara, BSN, RN	2674251383	carbonara@email.chop.edu
Contact: Kathryn Graham, BA	2155901859	GrahamK1@email.chop.edu

Locations

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United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathryn Graham, BA 215-590-1859 grahamk1@email.chop.edu

Sponsors and Collaborators

Children's Hospital of Philadelphia

National Heart, Lung, and Blood Institute (NHLBI)

University of Utah

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

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Principal Investigator:	Robert Sutton, MD MSCE	Children's Hospital of Philadelphia

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT02837497
Other Study ID Numbers:	15-012576 R01HL131544 ( U.S. NIH Grant/Contract ) UG1HD063108 ( U.S. NIH Grant/Contract )
First Posted:	July 19, 2016 Key Record Dates
Last Update Posted:	December 24, 2019
Last Verified:	December 2019

Keywords provided by Children's Hospital of Philadelphia:


pediatric heart arrest

Additional relevant MeSH terms:

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Heart Arrest Heart Diseases Cardiovascular Diseases

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