Lactic Acidosis During and After Seizures

Epilepsy Clinical Trial

Official title:

Lactic Acidosis During and After Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833247
• Other study ID #: Stanford Epilepsy IRB 21989
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: May 3, 2017
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project looks at the time course of lactic acid rise (if any) after seizures. Salivary and capillary lactic acid are tested. This type of measurement may be useful in signalling the occurrence or recent history of a seizure.

Description:

Lactic acid is released from cells during seizures and elevates lactic acid levels in blood and saliva. The time course of this rise is unknown. If lactic acid rises within a few minutes of a seizure, than it might be feasible to develop lactic acid sensors to provide notification of a recent seizure. This could lead to better safety monitoring for people with epilepsy. This study was designed to utilize a commercially available lactic acid sensor (investigators have no connection with the sensor manufacturer and purchased the device at list price) to measure salivary lactic acid levels after a seizure during inpatient video-EEG epilepsy monitoring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 inclusive.

2. History of at least one generalized tonic-clonic (grand mal) seizure prior to enrollment in the study.

3. Undergoing monitoring in the Stanford Epilepsy Monitoring Unit.

Exclusion Criteria:

4. Not pregnant.

5. Inability to understand and sign the consent form.

6. No known history of mitochondrial disease or other metabolic disorders expected to affect blood lactate.

7. No known history of thrombophlebitis or excessive tendency to bleeding. Not on coumadin. Aspirin or anti-platelet agents are not an exclusion.

8. No known peripheral vascular disease affecting blood circulation to the fingers.

9. No painful peripheral neuropathy.

10. No Raynaud's disease or phenomenon.

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Lactic
• Epilepsy
• Seizures

Locations

Country	Name	City	State
United States	Stanford Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Lactic Acid Levels With Seizures	The investigators will assess the salivary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in saliva , immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.	Within 10 minutes of end of the seizure
Primary	Capillary Lactic Acid Levels With Seizures	The investigators will assess the capillary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in blood, within 10 minutes after the end of a seizure. Units of measurement will be mM/L. Baseline lactate serum level is expected to be less than 2.2 mM/L.	Within 10 minutes of end of the seizure
Primary	Intravenous Lactic Acid Levels With Seizures	The investigators will assess the intravenous lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in serum collected by IV, immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.	Within 10 minutes of end of the seizure