Lactic Acidosis During and After Seizures

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Robert S. Fisher, M.D., Ph.D., Stanford University
ClinicalTrials.gov Identifier:
NCT01833247
First received: March 28, 2013
Last updated: April 12, 2013
Last verified: April 2013
  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 Intervention
Epilepsy
Other: Measurement of lactic acid with a seizure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Significant increase of blood and salivary lactic acid [ Time Frame: Within 10 minutes of end of the seizure ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Salivary and capillary lactic acid will be correlated after a seizure [ Time Frame: Within 10 minutes of a seizure ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Epilepsy inpatients
Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
Other: Measurement of lactic acid with a seizure

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833247

Locations
United States, California
Stanford Hospital
Stanford, California, United States, 94305-5235
Sponsors and Collaborators
Stanford University
  More Information

No publications provided

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
Study First Received: March 28, 2013
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
epilepsy
lactic acid
saliva
postictal

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014