Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes

Syncope Clinical Trial

Official title:

Serum Lactate in Convulsive Syncopes Compared to Non-convulsive Syncopes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062683
• Other study ID #: Laktat-2017
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2017
• Last updated: March 3, 2017
• Start date: January 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2017
• Source: RWTH Aachen University
• Contact: Oliver Matz, Dr.
• Phone: 00492418080954
• Email: omatz[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlactatemia
• Lactate Blood Increase
• Syncope

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Neurology/Department of Cardiology, University Hospital RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Matz O, Zdebik C, Zechbauer S, Bündgens 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the first measurements of serum lactate concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope		2 hours
Secondary	Comparison of the first measurements of serum prolactin concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope		2 hours
Secondary	Comparison of the first measurements of creatine kinase concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope		2 hours
Secondary	Comparison of the first measurements of pH value concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope		2 hours
Secondary	Comparison of the first measurements of bicarbonate concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope		2 hours
Secondary	Comparison of the first measurements of sodium and potassium concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope		2 hours