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

NCT ID: NCT02926703

Last Updated: 2016-10-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Seizure Syncope

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

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.

Reference Type BACKGROUND
PMID: 27367837 (View on PubMed)

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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