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NCT Number: NCT04511676

The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

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.

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Key information

Conditions

Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pharmongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Plasma concentration of Levetiracetam

    Time frame: Immediately before an initiation of an intermittent hemodialysis session

    Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day

  2. Plasma concentration of Levetiracetam

    Time frame: 1 hour after an initiation of an intermittent hemodialysis session

    Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day

  3. Plasma concentration of Levetiracetam

    Time frame: 2 hour after an initiation of an intermittent hemodialysis session

    Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day

  4. Plasma concentration of Levetiracetam

    Time frame: 3 hour after an initiation of an intermittent hemodialysis session

    Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day

  5. Plasma concentration of Levetiracetam

    Time frame: 4 hour after an initiation of an intermittent hemodialysis session

    Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day

  6. Plasma concentration of Levetiracetam

    Time frame: Before an administration of Levetiracetam post-hemodialysis supplemental dose

    Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day

  7. Plasma concentration of Levetiracetam

    Time frame: 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 outcomes

  1. Plasma concentration of Levetiracetam

    Time frame: Immediately before Levetiracetam administration

    Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day.

  2. Plasma concentration of Levetiracetam

    Time frame: 1 hour after finishing Levetiracetam administration

    Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day.

  3. Number of participants with adverse drug reactions from 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

    Observed signs and symptoms of Levetiracetam adverse drug reactions after participants were administered with Levetiracetam.

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Collaborators

  • Silpakorn University

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2020
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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