Clinical Trials Directory

Trials / Completed

CompletedNCT02926703

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

Status
Completed
Phase
Study type
Observational
Enrollment
85 (actual)
Sponsor
RWTH Aachen University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERSerum lactate and CK concentrations in blood samplesSerum lactate and CK concentrations in blood samples were measured routinely at admission

Timeline

Start date
2015-11-01
Primary completion
2016-08-01
Completion
2016-08-01
First posted
2016-10-06
Last updated
2016-10-07

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02926703. Inclusion in this directory is not an endorsement.