The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

Completed

• Conditions: Seizures

• Registration Number: NCT04511676
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Study First Submitted: 2020-07-31
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Study First Posted: 2020-08-13
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Patients who were at least 18 years old.
2. Patients who were diagnosed with seizure.
3. Patients who were undergoing intermittent hemodialysis and were treated with intravenous Levetiracetam not less than 2 days

Exclusion Criteria

1. Patients who were pregnant or lactating
2. Patients who were treated with intravenous Levetiracetam more than once a day
3. Patients who were undergoing sustained low efficiency dialysis (SLED)
4. Patients who have intermittent dialysis duration less than 3 hours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Levetiracetam	1 hour after finishing an administration of Levetiracetam post-hemodialysis supplemental dose	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of Levetiracetam	1 hour after finishing Levetiracetam administration	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day.
Number of participants with adverse drug reactions from Levetiracetam	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	Observed signs and symptoms of Levetiracetam adverse drug reactions after participants were administered with Levetiracetam.

Trial Locations

Locations (1)

Pharmongkutklao Hospital; 🇹🇭 Ratchathewi, Bangkok, Thailand