Epileptic SeizureNCT03163719
Impact of Early Lactate Dosage Compared to CK for Diagnosis of a Suspected Seizure
An observational study of Epileptic Seizure and Creatine Kinase, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epileptic Seizure, Creatine Kinase, Lactate
- What is being tested?
- CK and Lactate dosages
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2016to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient Refusal
- <18 years
- Pregnancy
- Sepsis, fever> 38 °
- Shock State
- Myocardial infarction
Show all 12Show fewer
- Unbalanced Diabetes
- Hepatocellular insufficiency
- Drug and Toxic Use
- Taking Metformin
- Significant muscle injuries
- Myopathy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Farès MOUSTAFA, 06 24 36 63 69, fmoustafa@chu-clermontferrand.fr
About this study
Official title: Impact of Early Lactate Dosage Compared to CK for Diagnosis of a Suspected Seizure, on Patient Admitted to an Emergency Unit
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.
Read more
Objectives:
To evaluate the value of blood CK and Lactate dosage in emergency procedures in the diagnosis of generalized seizures.
Read the 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.
- Being tested
- CK and Lactate dosages
- Keywords
- Seizure, Generalized convulsive seizure, Convulsions, Creatine Kinase, Lactate, Lactacidaemia, Diagnostic, Losing consciousness, Epilepsy, Epileptic generalized tonic-clonic seizure
- Medical subject headings
- Seizures, Epilepsy, Generalized, Disease, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK and Lactate dosagesDiagnostic 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".
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CK and Lactate dosages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of lactates measurement and CPK measurement
at admission and four hour after admission for a confirmed convulsive crisis
Measured: Less than 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start28 Nov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epileptic SeizureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163719
- Sponsor's protocol ID
- CHU-329
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Lactate Dosage Compared to CK for Diagnosis of a Suspected Seizure, on Patient Admitted to an Emergency Unit
- ClinicalTrials.gov ID
- NCT03163719
- Acronym / sponsor ID
- CHU-329
- Keywords
- Seizure, Generalized convulsive seizure, Convulsions, Creatine Kinase, Lactate, Lactacidaemia, Diagnostic, Losing consciousness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with generalized convulsive seizure | – | Diagnostic Test: CK and Lactate dosagesAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Patient Refusal
- <18 years
- Pregnancy
- Sepsis, fever> 38 °
- Shock State
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CK and Lactate dosagesA 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". | Diagnostic test | Patients with generalized convulsive seizure |
Primary outcome
Comparison of lactates measurement and CPK measurement
Time frame: Less than 4 hours
at admission and four hour after admission for a confirmed convulsive crisis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epileptic Seizure and Creatine Kinase, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of lactates measurement and CPK measurement (time frame: Less than 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.