Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-24 @ 3:26 AM
Study NCT ID:
NCT04791995
Status:
COMPLETED
Last Update Posted:
2022-09-26
First Post:
2021-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resuscitation and Capillary Reperfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-22', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Capillary refill time (CRT)', 'timeFrame': 'baseline (immediately after inclusion to the study)', 'description': 'Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC'}], 'secondaryOutcomes': [{'measure': 'Skin mottling score (SMS)', 'timeFrame': 'baseline (immediately after inclusion to the study = minute 0), minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first', 'description': 'Skin mottling score (Ait-Oufella, H., Lemoinne, S., Boelle, P.Y. et al. Mottling score predicts survival in septic shock. Intensive Care Med 37, 801-807 (2011). Best: 0 - no mottling to worst: 5 - mottling on the entire leg) for ROSC vs. noROSC'}, {'measure': 'Capillary blood lactate (Lac)', 'timeFrame': 'baseline (immediately after inclusion to the study, = minute 0), minute 4, 8, 12, 16, 20', 'description': 'Capillary lactate in mmol/L from the capillary bed of a finger for ROSC vs noROSC and for correlations with CRT, SMS'}, {'measure': 'Hospital mortality', 'timeFrame': 'baseline (immediately after inclusion to the study)', 'description': 'Correlation of CRT, SMS and Lac with hospital mortality'}, {'measure': 'Correlation of CRT, SMS and Lac and 30 days good neurological outcome', 'timeFrame': 'baseline (immediately after inclusion to the study)', 'description': 'Good neurological outcome at 30 days measured with Cerebral Performance Category (CPC 1-5 (1 best: good cerebral performance, 5 worst: brain dead), modified Rankin scale (mRs 0-6 (0 best: no symptoms, 6 worst: dead) and health utility index 3 (HUI-3, worst: -0,36 - best: 1)'}, {'measure': 'Correlation of CRT, SMS and Lac and hospital discharge good neurological outcome', 'timeFrame': 'baseline (immediately after inclusion to the study)', 'description': 'Good neurological outcome at hospital discharge measured with Cerebral Performance Category (CPC 1-5 (1 best: good cerebral performance, 5 worst: brain dead), modified Rankin scale (mRs 0-6 (0 best: no symptoms, 6 worst: dead) and health utility index 3 (HUI-3, worst: -0,36 - best: 1)'}, {'measure': 'Correlation of CRT/SMS and lactate', 'timeFrame': 'baseline (immediately after inclusion to the study)', 'description': 'Correlation of CRT/SMS and lactate'}, {'measure': 'Correlation of SMS and CRT', 'timeFrame': 'baseline (immediately after inclusion to the study)', 'description': 'Correlation of SMS and CRT'}, {'measure': 'Correlation of time since cardiac arrest and CRT/SMS/lactate', 'timeFrame': 'baseline (immediately after inclusion to the study)', 'description': 'Correlation of time since cardiac arrest and CRT/SMS/lactate'}, {'measure': 'Correlation of catecholamine demand during the first 48 hours after ROSC and CRT/SMS', 'timeFrame': 'from ROSC up to 48 hours after ROSC', 'description': 'Cumulative catecholamine demand during the first 48 hours after ROSC in correlation with CRT/SMS/Lac during resuscitation'}, {'measure': 'Capillary refill time (CRT)', 'timeFrame': 'minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first', 'description': 'Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['capillary refill time', 'skin mottling score', 'capillary lactate', 'microperfusion', 'cardiopulmonary resuscitation'], 'conditions': ['Cardiac Arrest', 'Cardiac Arrest, Out-Of-Hospital', 'Cardiopulmonary Arrest', 'Cardiopulmonary Arrest With Successful Resuscitation']}, 'referencesModule': {'references': [{'pmid': '39838473', 'type': 'DERIVED', 'citation': 'Mueller M, Holzer M, Losert H, Grassmann D, Ettl F, Gatterbauer M, Magnet I, Nuernberger A, Kienbacher CL, Gelbenegger G, Girsa M, Herkner H, Krammel M. The association of capillary refill time and return of spontaneous circulation during out-of-hospital cardiac arrest: an observational study. Crit Care. 2025 Jan 21;29(1):37. doi: 10.1186/s13054-025-05255-4.'}]}, 'descriptionModule': {'briefSummary': 'Persistent microperfusion alterations after return of spontaneous circulation (ROSC) are associated with poor survival. To our knowledge, no human studies evaluating microperfusion during cardiopulmonary resuscitation (CPR) with simple and pre-hospital available tests have been published. Capillary refill time (CRT) and skin-mottling-score (SMS) are parameters for microperfusion and evaluated in septic and cardiogenic shock. In animal studies, microperfusion was impaired during cardiac arrest, although not correlating with systemic blood pressure.\n\nThe aim of this study is to investigate the correlation between impaired microcirculation (as measured with CRT and SMS) during resuscitation and ROSC resp. neurological outcome. Our clinical impression in daily routine is, that the appearance of a patient undergoing CPR is often linked to the outcome. We hypothesize, that this is due to changes in microperfusion of the skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult out-of-hospital cardiac arrest patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients ≥18 years during cardiopulmonary resuscitation\n* witnessed cardiac arrest\n\nExclusion Criteria:\n\n* insufficient manpower (e.g. study team has to provide CPR)\n* hypovolemia (exsanguination, anaphylaxis, sepsis as underlying cause)\n* presumed or known COVID-19 disease\n* hypo-/hyperthermia (\\<36.0°, \\>37.5°C)\n* Raynaud's disease\n* Peripheral arterial disease"}, 'identificationModule': {'nctId': 'NCT04791995', 'acronym': 'ReCapp', 'briefTitle': 'Resuscitation and Capillary Reperfusion', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion', 'orgStudyIdInfo': {'id': '001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Vienna Municipal Emergency Service', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Michael Holzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Emergency Medicine, Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Michael Holzer', 'investigatorFullName': 'Michael Holzer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}