The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

NCT ID: NCT04511676

Last Updated: 2020-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seizures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Silpakorn University

OTHER

Sponsor Role collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pasiri Sithinamsuwan, MD

Role: STUDY_CHAIR

Pharmongkutklao Hospital and College of Medicine

Daraporn Rungprai, BCP

Role: STUDY_DIRECTOR

Faculty of Pharmacy, Silpakorn University

Juthathip Suphanklang, BCP

Role: STUDY_DIRECTOR

Faculty of Pharmacy, Silpakorn University

Wongsakorn Promken, B Pharm

Role: PRINCIPAL_INVESTIGATOR

The College of Pharmacotherapy of Thailand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pharmongkutklao Hospital

Ratchathewi, Bangkok, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

Patsalos PN. Pharmacokinetic profile of levetiracetam: toward ideal characteristics. Pharmacol Ther. 2000 Feb;85(2):77-85. doi: 10.1016/s0163-7258(99)00052-2.

Reference Type BACKGROUND
PMID: 10722121 (View on PubMed)

Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43(11):707-24. doi: 10.2165/00003088-200443110-00002.

Reference Type BACKGROUND
PMID: 15301575 (View on PubMed)

Smetana KS, Cook AM, Bastin ML, Oyler DR. Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy. J Crit Care. 2016 Dec;36:116-124. doi: 10.1016/j.jcrc.2016.06.023. Epub 2016 Jul 5.

Reference Type BACKGROUND
PMID: 27546759 (View on PubMed)

Engelbrecht L, Grobler CJ, Rheeders M. A simple and cost-effective HPLC-UV method for the detection of levetiracetam in plasma/serum of patients with epilepsy. Biomed Chromatogr. 2017 Oct;31(10). doi: 10.1002/bmc.3969. Epub 2017 Apr 20.

Reference Type BACKGROUND
PMID: 28294369 (View on PubMed)

Jarvie D, Mahmoud SH. Therapeutic Drug Monitoring of Levetiracetam in Select Populations. J Pharm Pharm Sci. 2018;21(1s):149s-176s. doi: 10.18433/jpps30081.

Reference Type BACKGROUND
PMID: 30096051 (View on PubMed)

Yamamoto J, Toublanc N, Kumagai Y, Stockis A. Levetiracetam pharmacokinetics in Japanese subjects with renal impairment. Clin Drug Investig. 2014 Nov;34(11):819-28. doi: 10.1007/s40261-014-0237-7.

Reference Type BACKGROUND
PMID: 25312351 (View on PubMed)

Shiue HJ, Taylor M, Sands KA. Comparison of Levetiracetam Dosing Regimens in End-Stage Renal Disease Patients Undergoing Intermittent Hemodialysis. Ann Pharmacother. 2017 Oct;51(10):862-865. doi: 10.1177/1060028017713294. Epub 2017 Jun 5.

Reference Type BACKGROUND
PMID: 28582998 (View on PubMed)

Wieruszewski PM, Kashani KB, Rabinstein AA, Frazee E. Levetiracetam Pharmacokinetics in a Critically Ill Anephric Patient on Intermittent Hemodialysis. Neurocrit Care. 2018 Apr;28(2):243-246. doi: 10.1007/s12028-017-0441-4.

Reference Type BACKGROUND
PMID: 28828726 (View on PubMed)

Company-Albir MJ, Ruiz-Ramos J, Solana Altabella A, Marques-Minana MR, Vicent C, Poveda JL. Haemodialysis significantly reduces serum levetiracetam levels inducing epileptic seizures: Case report. J Clin Pharm Ther. 2017 Dec;42(6):774-775. doi: 10.1111/jcpt.12568. Epub 2017 May 28.

Reference Type BACKGROUND
PMID: 28555936 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LEV-HD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Levetiracetam Treatment of Neonatal Seizures
NCT02550028 TERMINATED PHASE1/PHASE2
Dosing of Levetiracetam (Keppra) in Neonates
NCT01239212 COMPLETED PHASE1/PHASE2