SeizureNCT02926703
Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure
An observational study of Seizure and Syncope, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Serum lactate and CK concentrations in blood samples
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Aug 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Emergency department patients
Who may be able to join
- 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
Who cannot join
- Prisoner
- Age < 18 years old
- Competing explanations for serum lactate or CK elevation e.g. shock or trauma
- Lack of capacity for consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology/Emergency department, University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
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.
Read the 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.
- Being tested
- Serum lactate and CK concentrations in blood samples
- Keywords
- seizure, lactate, creatine kinase
- Medical subject headings
- Seizures, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum lactate and CK concentrations in blood samplesOther
Serum lactate and CK concentrations in blood samples were measured routinely at admission
| Study group | Role | What they receive |
|---|---|---|
| GTCS patients | Patients with generalized tonic-clonic seizures (GTCS) and whose serum lactate and creatine kinase (CK) concentrations in blood samples had been measured within 2 hours after the event. In a subgroup of patients follow up blood samples were taken at 10 to 48 hours after the seizure to allow longitudinal the comparison of both markers Receives: Other: Serum lactate and CK concentrations in blood samples | |
| Syncope patients | Patients with syncope and whose serum lactate and CK concentrations in blood samples had been measured within 2 hours after the event. In a subgroup of patients follow up blood samples were taken at 10 to 48 hours after the seizure to allow longitudinal the comparison of both markers. Receives: Other: Serum lactate and CK concentrations in blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeizureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Dafotakis, Dr., Study director, Department of Neurology, University Hospital RWTH Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926703
- Sponsor's protocol ID
- Laktat-2016
- Other IDs
- EK 267/15
- Status last verified
- Sep 2016
- First submitted
- 5 Oct 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Matz O, Zdebik C, Zechbauer S, Bundgens L, Litmathe J, Willmes K, Schulz JB, Dafotakis M. Lactate as a diagnostic marker in transient loss of consciousness. Seizure. 2016 Aug;40:71-5. doi: 10.1016/j.seizure.2016.06.014. Epub 2016 Jun 23.
PubMed 27367837
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure
- ClinicalTrials.gov ID
- NCT02926703
- Acronym / sponsor ID
- Laktat-2016
- Keywords
- seizure, lactate, creatine kinase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GTCS patients | – | Other: Serum lactate and CK concentrations in blood samplesPatients with generalized tonic-clonic seizures (GTCS) and whose serum lactate and creatine kinase (CK) concentrations in blood samples had been measured within 2 hours after the event. In a subgroup of patients follow up blood samples were taken at 10 to 48 hours after the seizure to allow longitudinal the comparison of both markers |
| Syncope patients | – | Other: Serum lactate and CK concentrations in blood samplesPatients with syncope and whose serum lactate and CK concentrations in blood samples had been measured within 2 hours after the event. In a subgroup of patients follow up blood samples were taken at 10 to 48 hours after the seizure to allow longitudinal the comparison of both markers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Prisoner
- Age < 18 years old
- Competing explanations for serum lactate or CK elevation e.g. shock or trauma
- Lack of capacity for consent
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 |
|---|---|---|
| Serum lactate and CK concentrations in blood samplesSerum lactate and CK concentrations in blood samples were measured routinely at admission | Other | GTCS patients, Syncope patients |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Background: PubMed 27367837Matz O, Zdebik C, Zechbauer S, Bundgens L, Litmathe J, Willmes K, Schulz JB, Dafotakis M. Lactate as a diagnostic marker in transient loss of consciousness. Seizure. 2016 Aug;40:71-5. doi: 10.1016/j.seizure.2016.06.014. Epub 2016 Jun 23.
- Individual participant dataSharing planned: No
Related trials for Seizure
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
RecruitingPhase 1
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Focal Seizures
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
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.
Manuel Dafotakis, Dr. study director
Department of Neurology, University Hospital RWTH Aachen, Germany
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 Seizure and Syncope, run by RWTH Aachen University at 1 site in Germany.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 7 Oct 2016. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02926703, which also lists 1 linked publication.
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 7 Oct 2016.