Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes

NCT ID: NCT03062683

Last Updated: 2017-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Syncope Lactate Blood Increase

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lactate, prolactin and creatine kinase conc.

Intervention Type OTHER

Lactate, prolactin and creatine kinase conc. in blood samples were measured

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.

Lactate, prolactin and creatine kinase conc.

Intervention Type OTHER

Lactate, prolactin and creatine kinase conc. in blood samples were measured

Interventions

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Lactate, prolactin and creatine kinase conc.

Lactate, prolactin and creatine kinase conc. in blood samples were measured

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with convulsive or non-convulsive syncopes
* 18 years or older

Exclusion Criteria

* Prisoner
* Age \< 18 years old
* Lack of capacity for consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Matz, Dr.

Role: STUDY_DIRECTOR

RWTH Aachen University Hospital

Locations

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Department of Neurology/Department of Cardiology, University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Oliver Matz, Dr.

Role: CONTACT

00492418080954

Anne Cornelissen, Dr.

Role: CONTACT

0049241800

Facility Contacts

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Oliver Matz, Dr.

Role: primary

00492418080954

Manuel Dafotakis, Dr.

Role: backup

00492418035289

References

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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.

Reference Type BACKGROUND
PMID: 27367837 (View on PubMed)

Other Identifiers

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Laktat-2017

Identifier Type: -

Identifier Source: org_study_id

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