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Status unknownNCT03062683Updated Mar 6, 2017

Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes

An observational study in Syncope and Lactate Blood Increase, sponsored by RWTH Aachen University. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-06.

Sponsored by RWTH Aachen University · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Syncope
  • Lactate Blood Increase

Keywords

  • lactate
  • syncope
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In context

Syncope

201 studies on the registry are indexed under Syncope; 36 are open to participants now.

This study's planned enrollment of 100 is below the median of 250 across 84 observational studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

RWTH Aachen University is the lead sponsor of 230 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

cardiological patients with syncopes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Prisoner
  • Age \< 18 years old
  • Lack of capacity for consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

  • 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.

Interventions

  • OtherLactate, prolactin and creatine kinase conc.

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 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

  3. 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

  4. 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

  5. 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

07

Study locations

1 of 1 sites recruiting
  • Department of Neurology/Department of Cardiology, University Hospital RWTH Aachen
    Aachen, NRW 52070, Germany
    Recruiting
    • Oliver Matz, Dr. · Contactomatz@ukaachen.de · 00492418080954
    • Manuel Dafotakis, Dr. · Contact00492418035289
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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2017 (actual). Primary completion is estimated for Dec 2017, 11 months after the start.

Of 44 observational studies under Syncope, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2017
First posted
Feb 23, 2017
StartActual
Jan 1, 2017
Primary completionEst.
Dec 31, 2017
CompletionEst.
Dec 31, 2017
Last update
Mar 6, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03062683
Responsible party
Sponsor
First posted
Feb 23, 2017
Start date
Jan 1, 2017
Primary completion
Dec 31, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Mar 6, 2017

Study contacts

Oliver Matz, Dr.
Contact
omatz@ukaachen.de
00492418080954
Anne Cornelissen, Dr.
Contact
acornelissen@ukaachen.de
0049241800
Oliver Matz, Dr.
study director · RWTH Aachen University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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