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Lactic Acidosis During and After Seizures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01833247
First Posted: April 16, 2013
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert S. Fisher, M.D., Ph.D., Stanford University
  Purpose
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.

Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Lactic Acidosis During and After Seizures

Resource links provided by NLM:


Further study details as provided by Robert S. Fisher, M.D., Ph.D., Stanford University:

Primary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: July 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epilepsy inpatients
Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833247


Locations
United States, California
Stanford Hospital
Stanford, California, United States, 94305-5235
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Robert S Fisher, MD, PhD Stanford University Department of Neurology
  More Information

Responsible Party: Robert S. Fisher, M.D., Ph.D., Professor of Neurology, Stanford University
ClinicalTrials.gov Identifier: NCT01833247     History of Changes
Other Study ID Numbers: Stanford Epilepsy IRB 21989
First Submitted: March 28, 2013
First Posted: April 16, 2013
Results First Submitted: April 12, 2016
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Robert S. Fisher, M.D., Ph.D., Stanford University:
epilepsy
lactic acid
saliva
postictal

Additional relevant MeSH terms:
Epilepsy
Seizures
Acidosis
Acidosis, Lactic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Acid-Base Imbalance
Metabolic Diseases