Lactic Acidosis During and After Seizures

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305-5235
      • Stanford hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Age range will be 18-75, men and women, all ethnic backgrounds to be eligible. Eligible population will be determined by who gets admitted to the epilepsy monitoring unit with a history of generalized tonic-clonic seizures.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Epilepsy inpatients; Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Robert S Fisher, MD, PhD, Stanford University Department of Neurology

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: epilepsy; saliva; lactic acid; postictal
• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Acid-Base Imbalance; Epilepsy; Seizures; Acidosis; Acidosis, Lactic
• Other Study ID Numbers: Stanford Epilepsy IRB 21989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: If subjects wish to know their lactic acid levels after a seizure, we will provide the information, although it currently has no therapeutic or prognostic implications.