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

NCT03163719 | Unknown

• 1 other identifier: CHU-329
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Seizure; Generalized convulsive seizure; Convulsions; Creatine Kinase; Lactate; Lactacidaemia; Diagnostic; Losing consciousness; Epilepsy; Epileptic generalized tonic-clonic seizure

Outcome Measures

Primary Outcomes (1)

• Comparison of lactates measurement and CPK measurement

  at admission and four hour after admission for a confirmed convulsive crisis

  Less than 4 hours

Study Arms (1)

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.

Diagnostic Test: CK and Lactate dosages

Interventions

CK and Lactate dosages 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".

Patients with generalized convulsive seizure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

MeSH Terms

Conditions

Seizures; Epilepsy, Generalized; Disease; Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Pathologic Processes

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Farès MOUSTAFA

CONTACT

06 24 36 63 69; fmoustafa@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 23, 2017
• Study Start: November 28, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

FR (1)