Impact of Early Lactate Dosage Compared to CK for Diagnosis of a Suspected Seizure

NCT ID: NCT03163719

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-28
• Study Completion Date: 2018-11-30

Brief Summary

Defining the origin of a seizure remains a difficult diagnosis. The presence of witness is not systematic, the clinical examination can be little contributory, and the delay recommended by the FSN is often surpassed for the realization of Creatine kinase (4h). In the event of a suspected seizure, an initial blood test with Creatine kinase and Lactates is often done on admission of the patient in other words before the 4hours delay.

It seems interesting to harmonize the practices, to limit the patient wait in the emergencies for a deferred dosage of CK at 4 hours from the seizure and to identify an early biological marker.

Objectives:

To evaluate the value of blood CK and Lactate dosage in emergency procedures in the diagnosis of generalized seizures.

Detailed Description

We propose to carry out a prospective, observational, monocentric study at the CHU of Clermont-Ferrand. This is a descriptive analysis of the kinetics of the Creatine kinase and Lactates rates collected at the admission of a patient consulting for strong suspicion of convulsive seizure, and at 4 hours from the generalized seizure.

A patient consulting the emergency department for suspected seizure will have an usual blood test at the admission in this context with notably ionogram, fasting glucose, venous gasometry. As the CHU purchased a venous and arterial gasometry reader for the emergency department, blood ionogram, Hb, lactates, HCO3-, pH are collected without delay.

The Creatine kinase dosage will be collected in the usual way as a "tube bottom".

As recommended by the French Society of Neurology, a new sample will be collected at 4 hours of seizure for a dosage of Creatine kinase. The determination of the lactates will be based on a "tube bottom".

It is the emergency practitioner who will decide whether or not to include the patient in the descriptive study, assisted by a standardized survey, enumerating the high probability of generalized seizure orientation characteristics (patient history, treatments including antiepileptics, anamnesis, witnesses presence, evocative clinic) The study only recruited cases of strong suspicion of generalized seizure, beginning less than 4 hours to compare the kinetics of Creatine kinase and Lactates at admission and 4 hours of the generalized seizure.

Conditions

Epileptic Seizure; Creatine Kinase; Lactate; Epileptic Generalized Tonic-clonic Seizure

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with generalized convulsive seizure

All adult patients (aged at least 18 years old) presenting to the CHU Clermont-Ferrand adult emergencies with a strong suspicion of generalized tonic-clonic seizure beginning less than 4 hours will be included. Each eligible patient will be proposed by a doctor, to participate to the study. The emergency doctor will verify the patient's inclusion and non-inclusion criteria.

CK and Lactate dosages

Intervention Type: DIAGNOSTIC_TEST

A patient consulting the emergency department for suspected seizure will have an usual blood test at the admission in this context with notably ionogram, fasting glucose, venous gasometry. As the CHU purchased a venous and arterial gasometry reader for the emergency department, blood ionogram, Hb, lactates, HCO3-, pH are collected without delay. The Creatine kinase dosage will be collected in the usual way as a "tube bottom". As recommended by the French Society of Neurology, a new sample will be collected at 4 hours of seizure for a dosage of Creatine kinase. The determination of the lactates will be based on a "tube bottom".

Interventions

CK and Lactate dosages

A patient consulting the emergency department for suspected seizure will have an usual blood test at the admission in this context with notably ionogram, fasting glucose, venous gasometry. As the CHU purchased a venous and arterial gasometry reader for the emergency department, blood ionogram, Hb, lactates, HCO3-, pH are collected without delay. The Creatine kinase dosage will be collected in the usual way as a "tube bottom". As recommended by the French Society of Neurology, a new sample will be collected at 4 hours of seizure for a dosage of Creatine kinase. The determination of the lactates will be based on a "tube bottom".

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Any generalized convulsive seizure defined by a transient loss of consciousness with the occurrence of tonic-clonic movements.
• Beginning less than 4 hours.
• In a highly evocative context of the crisis by the presence of: witnesses and/or Urine loss, Tongue bite and/or personal medical history of epilepsy and/or Favorable context: sleeping debt, drug withdrawal, lights stimulations, video games and/or Impression of "already lived", already experienced before the discomfort and/or Break contact, and/or Unusual posture with hypertonia and/or Amnesia of the episode and/or Post-episode Confusion
• Inaugural or recurrent

Exclusion Criteria

• Patient Refusal
• <18 years
• Pregnancy
• Sepsis, fever> 38 °
• Shock State
• Myocardial infarction
• Unbalanced Diabetes
• Hepatocellular insufficiency
• Drug and Toxic Use
• Taking Metformin
• Significant muscle injuries
• Myopathy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick LACARIN

Role: CONTACT

placarin@chu-clermontferrand.fr

04 73 75 11 95

Farès MOUSTAFA

Role: CONTACT

fmoustafa@chu-clermontferrand.fr

06 24 36 63 69

Facility Contacts

Patrick LACARIN

Role: primary

placarin@chu-clermontferrand.fr

04 73 75 11 95

Farès MOUSTAFA

Role: backup

fmoustafa@chu-clermontferrand.fr

06 24 36 63 69

Other Identifiers

CHU-329

Identifier Type: -

Identifier Source: org_study_id