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Completed

NCT Number: NCT01833247

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Hospital

Stanford, California, 94305-5235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 inclusive.
  • History of at least one generalized tonic-clonic (grand mal) seizure prior to enrollment in the study.
  • Undergoing monitoring in the Stanford Epilepsy Monitoring Unit.

Exclusion criteria

  • Not pregnant.
  • Inability to understand and sign the consent form.
  • No known history of mitochondrial disease or other metabolic disorders expected to affect blood lactate.
  • No known history of thrombophlebitis or excessive tendency to bleeding. Not on coumadin. Aspirin or anti-platelet agents are not an exclusion.
  • No known peripheral vascular disease affecting blood circulation to the fingers.
  • No painful peripheral neuropathy.
  • No Raynaud's disease or phenomenon.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 16, 2013
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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