Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 9:37 AM
Study NCT ID:
NCT07239908
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resuscitation Enhancement to Avoid Rearrest Through Evidence-based Strategies in Prehospital Post-resuscitation Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Prehospital post cardiac arrest care protocol for advanced life support ambulance'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 318}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rearrest rate', 'timeFrame': 'From return of spontaneous circulation to first 1 hour in emergency room', 'description': 'patient who has return of spontaneous circulation and then has no pulse again'}], 'secondaryOutcomes': [{'measure': 'Survival to dischrage', 'timeFrame': '30 days after admission', 'description': 'patient who survival after admit to hospital'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post cardiac arrest care', 'Out-of-hospital cardiac arrest', 'Prehospital care'], 'conditions': ['Out-of-hospital Cardiac Arrest (OHCA)']}, 'referencesModule': {'references': [{'pmid': '39006133', 'type': 'BACKGROUND', 'citation': 'Vos IA, Lucassen FG, Bens BWJ, Dercksen B, Postma R, Jorna EMF, Ter Maaten JC, Struys MMRF, Ter Avest E. Pre-hospital care after return of spontaneous circulation: Are we achieving our targets? Resusc Plus. 2024 Jun 21;19:100691. doi: 10.1016/j.resplu.2024.100691. eCollection 2024 Sep.'}, {'pmid': '39503017', 'type': 'BACKGROUND', 'citation': 'Dillon DG, Montoy JCC, Bosson N, Toy J, Kidane S, Ballard DW, Gausche-Hill M, Donofrio-Odmann J, Schlesinger SA, Staats K, Kazan C, Morr B, Thompson K, Mackey K, Brown J, Menegazzi JJ; California Resuscitation Outcomes Consortium. Rationale and development of a prehospital goal-directed bundle of care to prevent rearrest after return of spontaneous circulation. J Am Coll Emerg Physicians Open. 2024 Nov 5;5(6):e13321. doi: 10.1002/emp2.13321. eCollection 2024 Dec.'}, {'pmid': '36692410', 'type': 'BACKGROUND', 'citation': 'Toy J, Tolles J, Bosson N, Hauck A, Abramson T, Sanko S, Kazan C, Eckstein M, Gausche-Hill M, Schlesinger SA. Association between a Post-Resuscitation Care Bundle and the Odds of Field Rearrest after Successful Resuscitation from Out-of-Hospital Cardiac Arrest: A Pre/Post Study. Prehosp Emerg Care. 2024;28(1):98-106. doi: 10.1080/10903127.2023.2172633. Epub 2023 Feb 13.'}, {'pmid': '39088816', 'type': 'BACKGROUND', 'citation': 'Smida T, Price BS, Mizener A, Crowe RP, Bardes JM. Prehospital Post-Resuscitation Vital Sign Phenotypes are Associated with Outcomes Following Out-of-Hospital Cardiac Arrest. Prehosp Emerg Care. 2025;29(2):138-145. doi: 10.1080/10903127.2024.2386445. Epub 2024 Aug 15.'}, {'pmid': '36191809', 'type': 'BACKGROUND', 'citation': 'Smida T, Menegazzi JJ, Crowe RP, Weiss LS, Salcido DD. Association of prehospital hypotension depth and dose with survival following out-of-hospital cardiac arrest. Resuscitation. 2022 Nov;180:99-107. doi: 10.1016/j.resuscitation.2022.09.018. Epub 2022 Sep 30.'}, {'pmid': '25447433', 'type': 'BACKGROUND', 'citation': 'Salcido DD, Sundermann ML, Koller AC, Menegazzi JJ. Incidence and outcomes of rearrest following out-of-hospital cardiac arrest. Resuscitation. 2015 Jan;86:19-24. doi: 10.1016/j.resuscitation.2014.10.011. Epub 2014 Oct 23.'}, {'pmid': '20809686', 'type': 'BACKGROUND', 'citation': 'Salcido DD, Stephenson AM, Condle JP, Callaway CW, Menegazzi JJ. Incidence of rearrest after return of spontaneous circulation in out-of-hospital cardiac arrest. Prehosp Emerg Care. 2010 Oct-Dec;14(4):413-8. doi: 10.3109/10903127.2010.497902.'}, {'pmid': '21054177', 'type': 'BACKGROUND', 'citation': "Lerner EB, O'Connell M, Pirrallo RG. Rearrest after prehospital resuscitation. Prehosp Emerg Care. 2011 Jan-Mar;15(1):50-4. doi: 10.3109/10903127.2010.519820. Epub 2010 Nov 5."}, {'pmid': '21335581', 'type': 'BACKGROUND', 'citation': 'Chestnut JM, Kuklinski AA, Stephens SW, Wang HE. Cardiovascular collapse after return of spontaneous circulation in human out-of-hospital cardiopulmonary arrest. Emerg Med J. 2012 Feb;29(2):129-32. doi: 10.1136/emj.2010.108340. Epub 2011 Feb 18.'}, {'pmid': '32091295', 'type': 'BACKGROUND', 'citation': 'Woo JH, Cho JS, Lee CA, Kim GW, Kim YJ, Moon HJ, Park YJ, Lee KM, Jeong WJ, Choi IK, Choi HJ, Choi HJ. Survival and Rearrest in out-of-Hospital Cardiac Arrest Patients with Prehospital Return of Spontaneous Circulation: A Prospective Multi-Regional Observational Study. Prehosp Emerg Care. 2021 Jan-Feb;25(1):59-66. doi: 10.1080/10903127.2020.1733716. Epub 2020 Mar 20.'}, {'pmid': '20828914', 'type': 'BACKGROUND', 'citation': 'Berdowski J, Berg RA, Tijssen JG, Koster RW. Global incidences of out-of-hospital cardiac arrest and survival rates: Systematic review of 67 prospective studies. Resuscitation. 2010 Nov;81(11):1479-87. doi: 10.1016/j.resuscitation.2010.08.006. Epub 2010 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'Out-of-hospital cardiac arrest (OHCA) remains a leading global emergency condition with low survival to hospital discharge despite advances in cardiopulmonary resuscitation. Return of spontaneous circulation (ROSC) rates have improved; however, 30-50% of patients experience rearrest after ROSC, which is associated with significantly reduced survival. Preventable physiologic factors related to prehospital care - including hypoxia, hypotension, and hyperventilation - are frequently identified prior to rearrest. Evidence-based post-ROSC clinical bundles exist mainly for in-hospital settings, while structured prehospital post-resuscitation care protocols are limited, particularly in resource-constrained environments.\n\nThe RE-ARREST project aims to develop, implement, and evaluate an evidence-based prehospital post-resuscitation care protocol designed for paramedic-led Emergency Medical Services. The intervention includes structured monitoring, tailored oxygenation and ventilation targets, vasopressor use criteria (norepinephrine), fluid management decision support, teamwork communication, and operational training workshops using simulation.\n\nThis is a quasi-experimental pre-post interventional study conducted at the Siriraj Emergency Medical Service (SiEMS), Thailand. The study compares outcomes from retrospective pre-implementation cases with prospective post-implementation cases, including both patient-centered outcomes and provider compliance. Adult OHCA patients with ROSC achieved prehospital and transported to Siriraj Hospital are eligible. The estimated sample size is 318 participants (pre-intervention 212; post-intervention 106) over two years.\n\nThe primary outcome is the incidence of rearrest within 1 hour after ROSC during prehospital care and initial emergency department management. Secondary outcomes include protocol compliance, survival-to-admission, and survival-to-hospital-discharge. The protocol emphasizes feasibility, safety, and replicability to inform scalable EMS clinical practice guidelines.\n\nThis research is expected to provide novel evidence on targeted prehospital post-ROSC care and has the potential to reduce rearrest, improve neurologically favorable survival, and strengthen EMS system quality improvement efforts in Thailand and other low-to-middle-resource settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adult patients who has out-of-hospital cardiac arrest\n2. patients who has return of spontaneous circulation after OHCA\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07239908', 'acronym': 'RE-ARREST', 'briefTitle': 'Resuscitation Enhancement to Avoid Rearrest Through Evidence-based Strategies in Prehospital Post-resuscitation Care', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'Resuscitation Enhancement to Avoid Rearrest Through Evidence-based Strategies in Prehospital Post-resuscitation Care', 'orgStudyIdInfo': {'id': '801/2568(IRB4)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Conventional post cardiac arrest care by ALS unit in Bangkok Thailand'}, {'type': 'EXPERIMENTAL', 'label': 'Prehospital post cardiac arrest care protocol', 'description': 'Prehospital post cardiac arrest care protocol', 'interventionNames': ['Drug: Prehospital post cardiac arrest care protocol']}], 'interventions': [{'name': 'Prehospital post cardiac arrest care protocol', 'type': 'DRUG', 'description': 'Prehospital post cardiac arrest care including:\n\n1. Fluid assessment and resuscitation in prehospital phase\n2. Early vasopressor in prehospital phase\n3. Regular monitoriny end-tidal CO2 in prehospital phase', 'armGroupLabels': ['Prehospital post cardiac arrest care protocol']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sattha Riyapan, MD MPH', 'role': 'CONTACT', 'email': 'sattha.riy@mahidol.ac.th', 'phone': '+66994489090'}, {'name': 'Bongkot Somboonkul, BS', 'role': 'CONTACT', 'email': 'bongkot.somboonkul.work@gmail.com', 'phone': '+6624141672'}], 'overallOfficials': [{'name': 'Sattha Riyapan, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'only IPD used in the results publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sattha Riyapan', 'investigatorAffiliation': 'Siriraj Hospital'}}}}