An observational study in Seizures, sponsored by Phramongkutklao College of Medicine and Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by Phramongkutklao College of Medicine and Hospital · Observational
Levetiracetam (LEV) is one of second-generation antiepileptic drugs that has been used to treat partial and generalized epilepsy. LEV is eliminated from the systemic circulation by renal excretion. Therefore, patients with renal impairment may experience a reduced drug excretion and increased adverse drug reactions. Moreover, patients with end-stage renal disease who need dialysis may experience low serum LEV concentration because of drug loss via dialysis. LEV loss via dialysis can cause low serum level of LEV that insufficient for seizure control. The present study was aimed to evaluate pharmacokinetics of LEV in patients undergoing 4 hour-intermittent hemodialysis (IHD). The results of the study may benefit to determine the appropriate LEV initial dose and supplemental dose for patients undergoing IHD.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 12 is below the median of 150 across 235 observational studies indexed under Seizures.
Browse Seizures studies →Phramongkutklao College of Medicine and Hospital is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who were admitted to Phramongkutklao Hospital as inpatients.
Exclusion Criteria:
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
Time frame: Immediately before an initiation of an intermittent hemodialysis session
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
Time frame: 1 hour after an initiation of an intermittent hemodialysis session
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
Time frame: 2 hour after an initiation of an intermittent hemodialysis session
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
Time frame: 3 hour after an initiation of an intermittent hemodialysis session
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
Time frame: 4 hour after an initiation of an intermittent hemodialysis session
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
Time frame: Before an administration of Levetiracetam post-hemodialysis supplemental dose
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
Time frame: 1 hour after finishing an administration of Levetiracetam post-hemodialysis supplemental dose
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day.
Time frame: Immediately before Levetiracetam administration
Plasma concentration of Levetiracetam
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day.
Time frame: 1 hour after finishing Levetiracetam administration
Number of participants with adverse drug reactions from Levetiracetam
Observed signs and symptoms of Levetiracetam adverse drug reactions after participants were administered with Levetiracetam.
Time frame: From the first day that participants were included to the study and treated with Levetiracetam until the date of the last point of serum Levetiracetam sampling, assessed up to 3 days
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Phramongkutklao College of Medicine and Hospital