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Cardiac ArrestICU-RESUSNCT02837497

The ICU-Resuscitation Project (ICU-RESUS)

A study testing ICU-RESUS CPR Improvement Bundle in people with Cardiac Arrest, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 37 weeks to 18 years
Conditions the study is for
Cardiac Arrest
What is being tested?
ICU-RESUS CPR Improvement Bundle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,127 participants
Where
1 siteUnited States
Study dates
Oct 2016to Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 37 weeks to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Improving Outcomes After Pediatric Cardiac Arrest

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.

Read the 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.

Conditions
Cardiac Arrest
Being tested
ICU-RESUS CPR Improvement Bundle
Keywords
pediatric, heart arrest
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICU-RESUS CPR Improvement BundleOther

    Also called ICU-RESUS

    1. Point-of-care CPR training
    2. Post-cardiac arrest educational debriefings
Study groups in NCT02837497
Study groupRoleWhat they receive
ControlNo interventionStandard ICU resuscitation practices
ICU-RESUS CPR Improvement BundleExperimentalICU-RESUS bundle implementation: 1) point-of-care bedside CPR training; and 2) post-cardiac arrest debriefings.
Receives: Other: ICU-RESUS CPR Improvement Bundle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Good neurological survival

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

    Measured: Baseline and hospital discharge

Secondary outcomes (1)
  1. Excellent CPR

    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%.

    Measured: During cardiopulmonary resuscitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionMar 2021
  4. Study completionMar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
1,127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02837497
Sponsor's protocol ID
15-012576
Other IDs
R01HL131544, UG1HD063108
Acronym
ICU-RESUS
Status last verified
May 2021
First submitted
14 Jul 2016
Last updated
17 May 2021
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 26646466
  • 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.

    PubMed 25822236
  • 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.

    PubMed 25321490
  • 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.

    PubMed 24842846
  • 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.

    PubMed 24717462
  • 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.

    PubMed 24561563
  • Shepard LN, Friess SH, Reeder RW, Bender D, Berg RA, Graham K, Meert KL, Mourani PM, Murray R, Nadkarni VM, Nataraj C, Palmer CA, Patterson E, Srivastava N, Wolfe HA, Yates AR, Morgan RW, 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. Pediatric Cardiopulmonary Resuscitation Ventilation Rates and Outcomes. Crit Care Med. 2026 Oct 14. doi: 10.1097/CCM.0000000000007381. Online ahead of print.

    PubMed 42872941
  • Wolfe HA, Morgan RW, Reeder RW, Abdelsamad N, Ahmed T, Cooper KK, Franzon D, Graham K, Harding ML, Maa T, Meert KL, Nadkarni VM, Berg RA, Sutton RM; ICU-RESUS Investigators. Association of Chest Compression Metrics During Pediatric CPR With Intra-Arrest Blood Pressure and Survival Outcomes in the United States: Insights From ICU-RESUS. Circ Popul Health Outcomes. 2026 Sep 30:e013037. doi: 10.1161/CIRCOUTCOMES.125.013037. Online ahead of print.

    PubMed 42813260
  • 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.

    PubMed 41207462
  • 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.

    PubMed 40558671
  • 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.

    PubMed 40466056
  • 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.

    PubMed 39848427
  • 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.

    PubMed 39215367
  • 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.

    PubMed 38088765
  • 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.

    PubMed 37929615

Questions about this trial

What is this clinical trial studying?

A study testing ICU-RESUS CPR Improvement Bundle in people with Cardiac Arrest, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Good neurological survival (time frame: Baseline and hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02837497, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.

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