Clinical trial NCT03062683: Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes
Official title: Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope
Lactate Blood Increase
Keywords: lactate
syncope
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiological patients with syncopes

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 2 hours
Secondary outcomes:
measure: Comparison of the first measurements of serum prolactin concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope
timeFrame: 2 hours
measure: Comparison of the first measurements of creatine kinase concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
timeFrame: 2 hours
measure: Comparison of the first measurements of pH value concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
timeFrame: 2 hours
measure: Comparison of the first measurements of bicarbonate concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
timeFrame: 2 hours
measure: Comparison of the first measurements of sodium and potassium concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope
timeFrame: 2 hours
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Neurology/Department of Cardiology, University Hospital RWTH Aachen
state: NRW
Study officials:
affiliation: RWTH Aachen University Hospital
name: Oliver Matz, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.