Trial Outcomes & Findings for Lactic Acidosis During and After Seizures (NCT NCT01833247)

Last Updated: 2017-05-05

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

12 participants

Primary outcome timeframe

Within 10 minutes of end of the seizure

Results posted on

2017-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Epilepsy Inpatients Patients who have blood or salivary (or both) levels recorded after a seizure.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lactic Acidosis During and After Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epilepsy Inpatients n=12 Participants Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
Age, Continuous	40.8 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 10 minutes of end of the seizure

Outcome measures

Outcome measures
Measure	Epilepsy Inpatients n=12 Participants Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
Salivary Lactic Acid Levels With Seizures	8.16 mmol/L Standard Deviation 8.88

PRIMARY outcome

Timeframe: Within 10 minutes of end of the seizure

Population: Data were collected from 6 of the 12 enrolled subjects

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.

Outcome measures

Outcome measures
Measure	Epilepsy Inpatients n=6 Participants Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
Capillary Lactic Acid Levels With Seizures	5.67 mmol/L Standard Deviation 4.57

PRIMARY outcome

Timeframe: Within 10 minutes of end of the seizure

Population: Data were collected from one participant

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.

Outcome measures

Outcome measures
Measure	Epilepsy Inpatients n=1 Participants Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
Intravenous Lactic Acid Levels With Seizures	8.6 mmol/L

POST_HOC outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Epilepsy Inpatients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert S. Fisher, MD, PhD

Stanford University Department of Neurology

Phone: 650-7215289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place