Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-02 @ 1:59 PM
Study NCT ID:
NCT03172468
Status:
WITHDRAWN
Last Update Posted:
2025-01-22
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart 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': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'unable to facilitate patient recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-29', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Arterial Blood Pressure', 'timeFrame': 'immediately after placement of the arterial line', 'description': 'Mean arterial blood pressure measured invasively via the arterial line.'}], 'secondaryOutcomes': [{'measure': 'Systolic Arterial Blood Pressure', 'timeFrame': 'immediately after placement of the arterial line', 'description': 'Systolic arterial blood pressure measured invasively via the arterial line.'}, {'measure': 'Diastolic Arterial Blood Pressure', 'timeFrame': 'immediately after placement of the arterial line', 'description': 'Diastolic arterial blood pressure measured invasively via the arterial line.'}, {'measure': 'Mean Arterial Blood Pressure', 'timeFrame': 'one minute after the first application of epinephrine following placement of the arterial line', 'description': 'Mean arterial blood pressure measured invasively via the arterial line.'}, {'measure': 'Systolic Arterial Blood Pressure', 'timeFrame': 'one minute after the first application of epinephrine following placement of the arterial line', 'description': 'Systolic arterial blood pressure measured invasively via the arterial line.'}, {'measure': 'Diastolic Arterial Blood Pressure', 'timeFrame': 'one minute after the first application of epinephrine following placement of the arterial line', 'description': 'Diastolic arterial blood pressure measured invasively via the arterial line.'}, {'measure': 'Mean Arterial Blood Pressure', 'timeFrame': 'five minutes after placement of arterial line', 'description': 'Mean arterial blood pressure measured invasively via the arterial line.'}, {'measure': 'Systolic Arterial Blood Pressure', 'timeFrame': 'five minutes after placement of arterial line', 'description': 'Systolic arterial blood pressure measured invasively via the arterial line.'}, {'measure': 'Diastolic Arterial Blood Pressure', 'timeFrame': 'five minutes after placement of arterial line', 'description': 'Diastolic arterial blood pressure measured invasively via the arterial line.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'referencesModule': {'availIpds': [{'url': 'https://box.medunigraz.at/s/QuTYym3xsqXybWI', 'type': 'Informed Consent Form'}, {'url': 'https://box.medunigraz.at/s/YbufqAn3DBI1f4Q', 'type': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate, whether patients suffering from cardiac arrest, that can be successfully resuscitated, can be differentiated from those, that cannot be resuscitated, using arterial blood pressure values.', 'detailedDescription': 'Cardiopulmonary resuscitation (CPR) in patients suffering from cardiac arrest out of hospitals is based on strict clinical practice guidelines. However, the evidence base for these treatment recommendation is insufficient in many respects. While knowledge about basic interventions, that are capable of restoring spontaneous circulation and improving neurologically intact survival - chest compressions, application of oxygen and early defibrillation -, has increased over the last decade, advanced treatment options - advanced airway management, vascular access, application of vasoactive drugs - are still recommended, although clinical trials of varying quality failed to demonstrate any benefit in patient related outcomes.\n\nThis study seeks to establish hemodynamic threshold values that are able to discriminate between patients that achieve return of spontaneous circulation (survivors) and those that fail to do so (non-survivors). These cutoff values could act as targets for interventions during CPR (i.e. application of vasoactive drugs, use of mechanical compression devices, …) in further trials and may potentially influence clinical practice later on. Furthermore, reliable cutoff values could act as additional prognostic factors during CPR, enabling prehospital care providers to base their decisions to continue or terminate ongoing CPR efforts on a more solid basis.\n\nTo achieve this goal, 22 patients with out-of-hospital cardiac arrest (OHCA) treated by physicians of the prehospital physician response system located at the Medical University of Graz shall be included into this trial. All patients will receive Advanced Life Support (ALS) interventions according to current guidelines issued by the European Resuscitation Council (ERC). In addition, arterial lines will be placed and arterial blood pressure will be measured continuously. This intervention is already considered standard of care at this prehospital physician response system and performed routinely as part of the local ALS algorithm.\n\nRelevant parameters - systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP) etc. - will be documented electronically using both the electronic documentation system already used by the prehospital physician response system and the monitor/defibrillator device. Median values will be compared between survivors and non-survivors and possible threshold values will be calculated. Cutoff values that would be best suited to act as targets in future research and clinical practice will be identified by receiver operating characteristics (ROC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients suffering from cardiac arrest on arrival of the physician response unit are to be included, if ALS is deemed reasonable by the emergency physician. The groups to be compared are survivors (patients with sustained return of spontaneous circulation (ROSC) in the field who are transported to a hospital alive) and non-survivors (patients in whom CPR is terminated in the field).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Out-of-hospital cardiac arrest\n* Age \\>18 years\n* Advanced Life Support started\n* Arterial line placement possible\n\nExclusion Criteria\n\n* Obvious signs of death\n* Advanced Directives / Do Not Attempt Resuscitation Order\n* Cardiac arrest of traumatic etiology\n* Documented patient refusal in advance'}, 'identificationModule': {'nctId': 'NCT03172468', 'acronym': 'HETOCA', 'briefTitle': 'Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest: Advancing Advanced Life Support Towards Goal Directed Resuscitation', 'orgStudyIdInfo': {'id': 'HETOCA-2017-v1.1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survivors', 'description': 'Patients suffering from out-of-hospital cardiac arrest (OHCA), who achieve sustained return of spontaneous circulation (ROSC) following prehospital cardiopulmonary resuscitation.'}, {'label': 'Non-Survivors', 'description': 'Patients suffering from out-of-hospital cardiac arrest (OHCA), who are declared dead after prehospital cardiopulmonary resuscitation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Prehospital Physician Response System, Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Paul Zajic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Div. of General Anaesthesiology, Emergency- and Intensive Care Medicine, Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}