The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04511676

Enrollment

Registered

2020-08-13

Start date

2018-11-01

Completion date

2019-10-10

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizures

Keywords

Levetiracetam, Pharmacokinetics, Hemodialysis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma concentration of Levetiracetam	Immediately before an initiation of an intermittent hemodialysis session	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day

Secondary

Measure	Time frame	Description
Plasma concentration of Levetiracetam	Immediately before 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.

Countries

Thailand

Outcome results