Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-11 @ 6:19 AM
Study NCT ID:
NCT02926703
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2016-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D013575', 'term': 'Syncope'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '2-5 ml blood sample for the measurements of serum lactate and creatine kinase concentrations'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the first measurements of serum lactate and creatine kinase concentrations in blood samples between patients admitted with either a generalized tonic-clonic seizure or a syncope', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Comparison of the serum lactate concentrations at admission with the CK follow-up taken 10 to 48 hours after the event', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['seizure', 'lactate', 'creatine kinase'], 'conditions': ['Seizure', 'Syncope']}, 'referencesModule': {'references': [{'pmid': '27367837', 'type': 'BACKGROUND', 'citation': 'Matz O, Zdebik C, Zechbauer S, Bundgens L, Litmathe J, Willmes K, Schulz JB, Dafotakis M. Lactate as a diagnostic marker in transient loss of consciousness. Seizure. 2016 Aug;40:71-5. doi: 10.1016/j.seizure.2016.06.014. Epub 2016 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The investigators compared the feasibility of serum creatine kinase and serum lactate concentration as diagnostic markers to distinguish between generalized tonic-clonic seizures (GTCS) and syncopes in clinical settings that require fast-action treatment, such as in the emergency departments.', 'detailedDescription': 'The patients of this prospective study were selected from a sample of patients who were admitted to the emergency room of the University Hospital RWTH Aachen with an unclear impairment of consciousness. Only patients who later on were diagnosed as having experienced a GTCS or a syncope and whose serum lactate concentrations had been measured within 2 hours after the event were enrolled in the study. The investigators compared the specificity and sensitivity of the serum lactate concentrations at admission with the CK concentration at admission and the CK follow-up taken 10 to 48 hours after the event.\n\nThe values at admission were compared between patients from whom a blood sample was collected within 60 minutes after the event, and those from whom a blood sample was collected within 61-120 minutes after the event.\n\nThe comparison of initial lactate concentrations at admission with CK levels 10 - 48 hours later could only be performed on part of the patient collective because the other patients were already discharged at this time-point and could therefore not be included.\n\nThe initial blood samples were taken at patient arrival in the emergency room. The follow up was performed during the inpatient stay.\n\nSerum lactate and CK concentrations between patient groups were statistically compared with a Mann-Whitney-U test. We defined cut-off values and their sensitivity and specificity by Receiver Operating Characteristic (ROC) analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency department patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with generalized tonic-clonic seizures and syncopes and whose blood samples were taken within 2 hours after the event\n\n18 years or older\n\nObserved seizure\n\nTime of the event before admission was known\n\nDiagnosis of an epileptic seizure or syncope had been entered in the final discharge report\n\nExclusion Criteria:\n\nPrisoner\n\nAge \\< 18 years old\n\nCompeting explanations for serum lactate or CK elevation e.g. shock or trauma\n\nLack of capacity for consent'}, 'identificationModule': {'nctId': 'NCT02926703', 'briefTitle': 'Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure', 'orgStudyIdInfo': {'id': 'Laktat-2016'}, 'secondaryIdInfos': [{'id': 'EK 267/15', 'type': 'OTHER', 'domain': 'local ethics committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'GTCS patients', 'description': 'Patients with generalized tonic-clonic seizures (GTCS) and whose serum lactate and creatine kinase (CK) concentrations in blood samples had been measured within 2 hours after the event. In a subgroup of patients follow up blood samples were taken at 10 to 48 hours after the seizure to allow longitudinal the comparison of both markers', 'interventionNames': ['Other: Serum lactate and CK concentrations in blood samples']}, {'label': 'Syncope patients', 'description': 'Patients with syncope and whose serum lactate and CK concentrations in blood samples had been measured within 2 hours after the event. In a subgroup of patients follow up blood samples were taken at 10 to 48 hours after the seizure to allow longitudinal the comparison of both markers.', 'interventionNames': ['Other: Serum lactate and CK concentrations in blood samples']}], 'interventions': [{'name': 'Serum lactate and CK concentrations in blood samples', 'type': 'OTHER', 'description': 'Serum lactate and CK concentrations in blood samples were measured routinely at admission', 'armGroupLabels': ['GTCS patients', 'Syncope patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Neurology/Emergency department, University Hospital RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Manuel Dafotakis, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Neurology, University Hospital RWTH Aachen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}