Clinical Trial: Lactic Acidosis During and After Seizures

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Lactic Acidosis During and After Seizures

Brief 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.

Detailed Summary: 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.
Sponsor: Stanford University

Current Primary Outcome:

  • Salivary Lactic Acid Levels With Seizures [ Time Frame: Within 10 minutes of end of the seizure ]
    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.
  • Capillary Lactic Acid Levels With Seizures [ Time Frame: Within 10 minutes of end of the seizure ]
    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.
  • Intravenous Lactic Acid Levels With Seizures [ Time Frame: Within 10 minutes of end of the seizure ]
    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.


Original Primary Outcome: Significant increase of blood and salivary lactic acid [ Time Frame: Within 10 minutes of end of the seizure ]

The investigators will assess the time course of lactic acid change after a seizure. Values will consist of lactic acid measurements in blood and saliva with baseline (pre-seizure), immediately post-seizure, then at 30 mins and 2 hours. 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. A useful outcome of this study will be identification of lactic acid above 4.4 mM/L (more than doubling) within 5 minutes of a seizure, occurring in at least half of the subjects.


Current Secondary Outcome:

Original Secondary Outcome: Salivary and capillary lactic acid will be correlated after a seizure [ Time Frame: Within 10 minutes of a seizure ]

Salivary levels of lactic acid is being studied because saliva is more accessible in the outpatient setting than is blood. Concentration of lactic acid in the serum and saliva from each individual subject will be correlated using Pearson's correlation test. We will consider a positive outcome to be a r greater than or equal to 0.5 and significance at p<0.05.


Information By: Stanford University

Dates:
Date Received: March 28, 2013
Date Started: July 2012
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017