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

Syncope Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926703
• Other study ID #: Laktat-2016
• Secondary ID: EK 267/15
• Status: Completed
• Phase: N/A
• First received: October 5, 2016
• Last updated: October 6, 2016
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy
• Seizure
• Seizures
• Syncope

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Neurology/Emergency department, University Hospital RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Matz O, Zdebik C, Zechbauer S, Bündgens 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 hours	No
Secondary	Comparison of the serum lactate concentrations at admission with the CK follow-up taken 10 to 48 hours after the event		48 hours	No