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

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ClinicalTrials.gov Identifier: NCT02926703
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
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.

Condition or disease Intervention/treatment
Seizure Syncope Other: Serum lactate and CK concentrations in blood samples

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.


Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure
Study Start Date : November 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting Seizures

Group/Cohort Intervention/treatment
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
Other: 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.
Other: Serum lactate and CK concentrations in blood samples
Serum lactate and CK concentrations in blood samples were measured routinely at admission




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
2-5 ml blood sample for the measurements of serum lactate and creatine kinase concentrations


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency department patients
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926703


Locations
Germany
Department of Neurology/Emergency department, University Hospital RWTH Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Director: Manuel Dafotakis, Dr. Department of Neurology, University Hospital RWTH Aachen, Germany

Publications:
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02926703     History of Changes
Other Study ID Numbers: Laktat-2016
EK 267/15 ( Other Identifier: local ethics committee )
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by RWTH Aachen University:
seizure
lactate
creatine kinase

Additional relevant MeSH terms:
Seizures
Syncope
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations