SyncopeNCT03062683
Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes
An observational study of Syncope and Lactate Blood Increase, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The investigators compared the serum lactate, serum prolactin and serum creatine kinase concentrations following convulsive and non-convulsive syncopes. The aim of the study was to investigate their importance as diagnostic markers in transient loss of consciousness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Lactate Blood Increase
- What is being tested?
- Lactate, prolactin and creatine kinase conc.
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 31 Dec 2017
- 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: cardiological patients with syncopes
Who may be able to join
- Patients with convulsive or non-convulsive syncopes
- 18 years or older
Who cannot join
- Prisoner
- Age < 18 years old
- Lack of capacity for consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology/Department of Cardiology, University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52070
Oliver Matz, Dr., 00492418080954, omatz@ukaachen.de
Manuel Dafotakis, Dr., 00492418035289
About this study
The investigators compared the serum lactate, serum prolactin and serum creatine kinase concentrations following convulsive and non-convulsive syncopes. The aim of the study was to investigate their importance as diagnostic markers in transient loss of consciousness.
Read the detailed description
Unclear transient loss of consciousness is a frequent interdisciplinary diagnostic problem. Of particular importance is the distinction between epileptic and non-epileptic events. Our group showed in two previous studies that serum lactate is elevated in epileptic seizures, but mostly not in syncopes, psychogenic non-epileptic seizures and complex partial seizures. These results showed that lactate can be used as a diagnostic marker for the presence of a generalized epileptic seizure.It remains unclear whether a normal serum lactate value is also present in a convulsive syncope as the most important differential diagnosis to generalized epileptic seizures.
So in the present prospective study, the serum lactate concentrations are compared following convulsive and non-convulsive syncopes.
The examinations are carried out in cardiological patients who receive a tipping table examination with the aim of initiating a syncope. The question is whether there is hyperlactatemia following convulsive syncopes. If no elevated serum lactate values were measured after convulsive syncopes, this would additionally indicate the great benefit of the serum lactate value as a diagnostic marker in the generalized epileptic seizure.
In addition, a comparison is made with the parameters creatine kinase, prolactin, pH-value, bicarbonate, sodium and potassium.
If increased serum lactate values are measured following a syncope further venous blood controls are carried out at intervals of 20 minutes within the first hour and then after 90 minutes and 120 minutes until normalization.
- Conditions
- Syncope, Lactate Blood Increase
- Being tested
- Lactate, prolactin and creatine kinase conc.
- Keywords
- lactate, syncope
- Medical subject headings
- Syncope, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate, prolactin and creatine kinase conc.Other
Lactate, prolactin and creatine kinase conc. in blood samples were measured
| Study group | Role | What they receive |
|---|---|---|
| Non-convulsive syncope patients | Patients with a non-convulsive syncope triggered by a tilting table examination and whose serum lactate, prolactin and creatine kinase conc. in blood samples had been measured after the event. Receives: Other: Lactate, prolactin and creatine kinase conc. | |
| Convulsive syncope patients | Patients with a convulsive syncope triggered by a tilting table examination and whose serum lactate, prolactin and creatine kinase conc. in blood samples had been measured after the event. Receives: Other: Lactate, prolactin and creatine kinase conc. |
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 concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope
Measured: 2 hours
Secondary outcomes (5)
Comparison of the first measurements of serum prolactin concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope
Measured: 2 hours
Comparison of the first measurements of creatine kinase concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
Measured: 2 hours
Comparison of the first measurements of pH value concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
Measured: 2 hours
Comparison of the first measurements of bicarbonate concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
Measured: 2 hours
Comparison of the first measurements of sodium and potassium concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
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 SyncopeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Matz, Dr., Study director, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062683
- Sponsor's protocol ID
- Laktat-2017
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes
- ClinicalTrials.gov ID
- NCT03062683
- Acronym / sponsor ID
- Laktat-2017
- Conditions
- Syncope, Lactate Blood Increase
- Keywords
- lactate, syncope
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 23 Feb 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.
The investigators compared the serum lactate, serum prolactin and serum creatine kinase concentrations following convulsive and non-convulsive syncopes. The aim of the study was to investigate their importance as diagnostic markers in transient loss of consciousness.
Detailed description
Unclear transient loss of consciousness is a frequent interdisciplinary diagnostic problem. Of particular importance is the distinction between epileptic and non-epileptic events. Our group showed in two previous studies that serum lactate is elevated in epileptic seizures, but mostly not in syncopes, psychogenic non-epileptic seizures and complex partial seizures. These results showed that lactate can be used as a diagnostic marker for the presence of a generalized epileptic seizure.It remains unclear whether a normal serum lactate value is also present in a convulsive syncope as the most important differential diagnosis to generalized epileptic seizures.
So in the present prospective study, the serum lactate concentrations are compared following convulsive and non-convulsive syncopes.
The examinations are carried out in cardiological patients who receive a tipping table examination with the aim of initiating a syncope. The question is whether there is hyperlactatemia following convulsive syncopes. If no elevated serum lactate values were measured after convulsive syncopes, this would additionally indicate the great benefit of the serum lactate value as a diagnostic marker in the generalized epileptic seizure.
In addition, a comparison is made with the parameters creatine kinase, prolactin, pH-value, bicarbonate, sodium and potassium.
If increased serum lactate values are measured following a syncope further venous blood controls are carried out at intervals of 20 minutes within the first hour and then after 90 minutes and 120 minutes until normalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-convulsive syncope patients | – | Other: Lactate, prolactin and creatine kinase conc.Patients with a non-convulsive syncope triggered by a tilting table examination and whose serum lactate, prolactin and creatine kinase conc. in blood samples had been measured after the event. |
| Convulsive syncope patients | – | Other: Lactate, prolactin and creatine kinase conc.Patients with a convulsive syncope triggered by a tilting table examination and whose serum lactate, prolactin and creatine kinase conc. in blood samples had been measured after the event. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cardiological patients with syncopes
Key inclusion criteria (2 listed)
- Patients with convulsive or non-convulsive syncopes
- 18 years or older
Key exclusion criteria (3 listed)
- Prisoner
- Age < 18 years old
- 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 |
|---|---|---|
| Lactate, prolactin and creatine kinase conc.Lactate, prolactin and creatine kinase conc. in blood samples were measured | Other | Convulsive syncope patients, Non-convulsive syncope patients |
Primary outcome
Comparison of the first measurements of serum lactate concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope
Time frame: 2 hours
5 secondary outcomes
Comparison of the first measurements of serum prolactin concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope
Time frame: 2 hours
Comparison of the first measurements of creatine kinase concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
Time frame: 2 hours
Comparison of the first measurements of pH value concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
Time frame: 2 hours
Comparison of the first measurements of bicarbonate concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
Time frame: 2 hours
Comparison of the first measurements of sodium and potassium concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- 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
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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.
Oliver Matz, Dr. study director
RWTH Aachen University Hospital
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 Syncope and Lactate Blood Increase, 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 2 inclusion and 3 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 6 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Matz, Dr. (00492418080954, omatz@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the first measurements of serum lactate concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive 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 NCT03062683, 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 6 Mar 2017.