Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-29 @ 12:04 AM
Study NCT ID:
NCT01362556
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Gas Analysis and Buffering In 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017693', 'term': 'Sodium Bicarbonate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-02', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-05-26', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of return of spontaneous circulation (ROSC)', 'timeFrame': 'Within five hours from start of resuscitation.'}], 'secondaryOutcomes': [{'measure': 'Survival to discharge after cardiac arrest', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 weeks', 'description': 'Discharge from hospital'}, {'measure': 'Survival after one year of hospital discharge', 'timeFrame': 'One year after event'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The debate over the administration of sodium bicarbonate in cardiac arrest has been going on for several decades, swinging like a pendulum from "first-line drug" to "not indicated" to the recent guidelines advocating "a small bolus under special conditions (metabolic acidosis, intoxication, long-term resuscitation)". A targeted, blood-gas controlled application under optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary studies have shown that an arterial puncture/line as well as measurement of blood gases is feasible in preclinical conditions. This multicentre trial including 5 centres and 10 physician-staffed emergency systems is designed to compare, in a prospective randomised controlled study, the effect of a calculated dosage of sodium bicarbonate based on the patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the secondary survival of cardiac arrest patients. The null hypothesis is that there is no or negative impact on survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prehospitally started cardiopulmonary resuscitation (CPR)\n* advanced cardiac life support provided\n* age \\>18 years\n* arterial pH \\< 7,2\n* arterial BE \\< -12\n* arterial pCO2 15-75 mmHg\n* arterial pO2 \\>35 mmHg\n\nExclusion Criteria:\n\n* women of childbearing age\n* traumatic cardiac arrest'}, 'identificationModule': {'nctId': 'NCT01362556', 'acronym': 'BABICA', 'briefTitle': 'Blood Gas Analysis and Buffering In Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Blood Gas Analysis and Buffering In Cardiac Arrest - A Multicenter, Prospective, Randomised, Double Blind Prehospital Trial to Evaluate the Impact of Early Blood-gas-analysis Targeted Buffer Therapy on ROSC After OOHCA', 'orgStudyIdInfo': {'id': 'BABICA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium Chloride', 'description': 'Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest.', 'interventionNames': ['Drug: Sodium Chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium Bicarbonate', 'description': 'Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest.', 'interventionNames': ['Drug: Sodium bicarbonate']}], 'interventions': [{'name': 'Sodium bicarbonate', 'type': 'DRUG', 'description': 'Administration of a calculated amount of sodium bicarbonate 8% \\[SB\\] after arterial blood gas measurement according to Base Excess \\[BE\\] and Body weight \\[kg\\].\n\nFormula: SB \\[ml\\] = -BE \\* kg \\* 0.1', 'armGroupLabels': ['Sodium Bicarbonate']}, {'name': 'Sodium Chloride', 'type': 'DRUG', 'description': 'Administration of a calculated amount of sodium chloride 0.9% \\[SC\\] after arterial blood gas measurement according to Base Excess \\[BE\\] and Body weight \\[kg\\].\n\nFormula: SC \\[ml\\] = -BE \\* kg \\* 0.1', 'armGroupLabels': ['Sodium Chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9020', 'city': 'Klagenfurt', 'state': 'Carinthia', 'country': 'Austria', 'facility': 'Landeskrankenhaus Klagenfurt', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': '2700', 'city': 'Wiener Neustadt', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'Landesklinikum Wiener Neustadt', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}, {'zip': '8600', 'city': 'Bruck / Mur', 'state': 'Styria', 'country': 'Austria', 'facility': 'Landeskrankenhaus Bruck / Mur'}, {'zip': '8020', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'LKH Graz West', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '4021', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'AKH Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'overallOfficials': [{'name': 'Gerhard Prause, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Dr', 'investigatorFullName': 'Prause Gerhard, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}