Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2016

Detailed Description

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. 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.

Interventions

  • Other: Serum lactate and CK concentrations in blood samples
    • Serum lactate and CK concentrations in blood samples were measured routinely at admission

Arms, Groups and Cohorts

  • 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
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 2 hours

Secondary Measures

  • Comparison of the serum lactate concentrations at admission with the CK follow-up taken 10 to 48 hours after the event
    • Time Frame: 48 hours

Participating in This Clinical Trial

Inclusion Criteria

Patients with generalized tonic-clonic seizures and syncopes and whose blood samples were taken within 2 hours after the event 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:

Prisoner Age < 18 years old Competing explanations for serum lactate or CK elevation e.g. shock or trauma Lack of capacity for consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RWTH Aachen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Manuel Dafotakis, Dr., Study Director, Department of Neurology, University Hospital RWTH Aachen, Germany

References

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.

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