Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure
NCT ID: NCT02926703
Last Updated: 2016-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
85 participants
OBSERVATIONAL
2015-11-30
2016-08-31
Brief Summary
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Detailed Description
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The 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.
The 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.
The initial blood samples were taken at patient arrival in the emergency room. The follow up was performed during the inpatient stay.
Serum 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GTCS patients
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
Serum lactate and CK concentrations in blood samples
Serum lactate and CK concentrations in blood samples were measured routinely at admission
Syncope patients
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.
Serum lactate and CK concentrations in blood samples
Serum lactate and CK concentrations in blood samples were measured routinely at admission
Interventions
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Serum lactate and CK concentrations in blood samples
Serum lactate and CK concentrations in blood samples were measured routinely at admission
Eligibility Criteria
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Inclusion Criteria
18 years or older
Observed seizure
Time of the event before admission was known
Diagnosis of an epileptic seizure or syncope had been entered in the final discharge report
Exclusion Criteria
Age \< 18 years old
Competing explanations for serum lactate or CK elevation e.g. shock or trauma
Lack of capacity for consent
18 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Manuel Dafotakis, Dr.
Role: STUDY_DIRECTOR
Department of Neurology, University Hospital RWTH Aachen, Germany
Locations
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Department of Neurology/Emergency department, University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
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References
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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.
Other Identifiers
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EK 267/15
Identifier Type: OTHER
Identifier Source: secondary_id
Laktat-2016
Identifier Type: -
Identifier Source: org_study_id
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