Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes

March 3, 2017 updated by: RWTH Aachen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52070
        • Recruiting
        • Department of Neurology/Department of Cardiology, University Hospital RWTH Aachen
        • Contact:
        • Contact:
          • Manuel Dafotakis, Dr.
          • Phone Number: 00492418035289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cardiological patients with syncopes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Lactate, prolactin and creatine kinase conc.
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.
Other: Lactate, prolactin and creatine kinase conc.
Lactate, prolactin and creatine kinase conc. in blood samples were measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Study Director: Oliver Matz, Dr., RWTH Aachen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laktat-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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