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OpenTrials
Completed

NCT Number: NCT02926703

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology/Emergency department, University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum lactate and CK concentrations in blood samples

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2016
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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