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Continuous Renal Replacement Therapy (CRRT)LEVCRRTNCT07918833

Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy

An observational study of Continuous Renal Replacement Therapy (CRRT) and Pharmacokinetics, run by Chulalongkorn University at 1 site in Thailand.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Levetiracetam may be removed during continuous renal replacement therapy (CRRT), potentially affecting drug concentrations and seizure control. The optimal dosing regimen for critically ill patients receiving CRRT remains unclear. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Levetiracetam
How many people
15 participants
Where
1 siteThailand
Study dates
30 Oct 2026to 30 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Critically ill adult patients aged 18 years or older admitted to ICUs who receive levetiracetam during CRRT. Eligible patients must have received CRRT for at least 24 hours and meet the study's inclusion and exclusion criteria.

Who may be able to join

  • Adults aged 18 years or older.
  • Patients admitted to any ICUs.
  • Patients receiving CRRT for at least 24 hours.
  • Hemodynamically stable patients, defined as having a SBP of at least 90 mmHg or a MAP of at least 60 mmHg, with the norepinephrine dose remaining stable or increasing by no more than 0.1 mcg/kg/min during the preceding 6 hours.
  • Patients receiving intravenous or oral levetiracetam while receiving CRRT.
  • Patients admitted to any ICUs.
  • Patients receiving CRRT for at least 24 hours.

Who cannot join

  • Pregnant patients
  • Patients who are breastfeeding.
  • Patients with a known hypersensitivity to levetiracetam or who develop a hypersensitivity reaction requiring discontinuation of levetiracetam during the study.
  • Patients with cirrhosis classified as Child-Pugh-Turcotte class C.
  • Patients receiving extracorporeal membrane oxygenation (ECMO).
  • Patients who, or whose legally authorized representatives, do not provide informed consent for study participation.
  • Patients with an expected survival of less than 24 hours, as assessed by the attending physician.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Supanat Khueankaew, PharmD contact

+6622188403

supanat.khnat@gmail.com

Thailand1 site
  • King Chulalongkorn Memorial Hospital

    Pathum Wan, Bangkok, 10330

    Supanat Khueankaew, PharmD, +6622188403, supanat.khnat@gmail.com

    Weerachai Chaijamorn, BSc(Pharm), BCP, FACP, BCPS, +6622188403, weerachai.c@chula.ac.th

Other trials in Thailand

About this study

Levetiracetam may be removed during continuous renal replacement therapy (CRRT), potentially affecting drug concentrations and seizure control. The optimal dosing regimen for critically ill patients receiving CRRT remains unclear. This observational study will investigate the pharmacokinetics of levetiracetam in critically ill adult patients receiving CRRT. Blood, CRRT effluent, and urine samples will be collected throughout one dosing interval to measure levetiracetam concentrations. The data will be used to develop a population pharmacokinetic model and perform pharmacokinetic/pharmacodynamic modeling and Monte Carlo simulations to evaluate dosing regimens and estimate the probability of achieving predefined drug concentration or exposure targets. The findings may help identify an appropriate levetiracetam dosing regimen for critically ill patients receiving CRRT.

Being tested
Levetiracetam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevetiracetamDrug

    Levetiracetam administered as part of routine clinical care to critically ill adult patients receiving CRRT. The dose, dosing interval, and route of administration are determined by the treating physician. CRRT is prescribed and managed by the treating clinical team (nephrologist) as part of routine clinical care. The investigators do not assign or modify levetiracetam treatment or CRRT prescriptions for research purposes. Levetiracetam concentrations are measured in blood, CRRT effluent, and urine samples collected at protocol-specified time points to characterize its pharmacokinetic profile during CRRT.

Study groups in NCT07918833
Study groupRoleWhat they receive
Critically Ill Adult Patients Receiving Levetiracetam During CRRTCritically ill adult patients aged 18 years or older admitted to ICUs who receive levetiracetam during CRRT. Eligible participants must have received CRRT for at least 24 hours and meet the study's inclusion and exclusion criteria.
Receives: Drug: Levetiracetam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probability of target attainment for simulated levetiracetam dosing regimens

    Monte Carlo simulations based on the developed population pharmacokinetic model will be used to estimate the probability of target attainment (PTA) for each simulated levetiracetam dosing regimen. Target attainment will be evaluated according to the prespecified therapeutic concentration and AUC target criteria in the study protocol. Results will be reported as the probability or percentage of simulated patients achieving the target for each dosing regimen.

    Measured: At completion of population pharmacokinetic model development and Monte Carlo simulations (approximately 23 months after study start).

Secondary outcomes (10)
  1. Levetiracetam plasma exposure based on the area under the concentration-time curve (AUC)

    Levetiracetam AUC will be estimated using noncompartmental analysis of concentration-time data collected over a single dosing interval. Simultaneous samples will be collected from the pre-filter, post-filter, and effluent ports before dosing and at 7 prespecified time points after intravenous or oral administration.

    Measured: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.

  2. Volume of distribution of levetiracetam

    The volume of distribution of levetiracetam will be estimated using noncompartmental pharmacokinetic analysis based on the administered dose, elimination rate constant, and AUC.

    Measured: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.

  3. Total clearance of levetiracetam

    Total clearance of levetiracetam will be estimated using noncompartmental pharmacokinetic analysis based on the administered dose and AUC.

    Measured: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.

  4. Levetiracetam sieving and saturation coefficients during continuous renal replacement therapy (CRRT)

    The sieving coefficient (SC) and saturation coefficient (SA) of levetiracetam will be determined using pre-filter, post-filter, and effluent concentrations to evaluate drug transfer across the CRRT filter under different CRRT modalities, including continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF).

    Measured: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.

  5. Levetiracetam clearance by CRRT

    Levetiracetam clearance by CRRT will be calculated based on pre-filter, post-filter, and effluent concentrations, together with replacement or dialysate flow rates according to the CRRT modality and dilution method, including CVVH, CVVHD, and CVVHDF.

    Measured: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.

  6. Renal clearance of levetiracetam

    Renal clearance of levetiracetam will be calculated based on urinary levetiracetam concentrations, urine volume, and plasma levetiracetam concentrations.

    Measured: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.

  7. Non-renal clearance of levetiracetam

    Non-renal clearance of levetiracetam will be estimated from total systemic drug clearance after accounting for renal and CRRT clearance.

    Measured: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.

  8. Population typical value of levetiracetam clearance

    The typical population value of levetiracetam clearance will be estimated using nonlinear mixed-effects modeling based on pre-filter and post-filter plasma concentration data collected from critically ill patients receiving CRRT.

    Measured: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).

  9. Population typical value of levetiracetam volume of distribution

    The typical population value of levetiracetam volume of distribution will be estimated using nonlinear mixed-effects modeling based on pre-filter and post-filter plasma concentration data collected from critically ill patients receiving CRRT.

    Measured: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).

  10. Population typical value of CRRT-mediated levetiracetam clearance

    The typical population value of CRRT-mediated levetiracetam clearance will be estimated using levetiracetam concentrations in plasma and effluent fluid, together with effluent flow rate, in critically ill patients receiving CRRT.

    Measured: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07918833
Sponsor's protocol ID
0551/2026
Acronym
LEVCRRT
Status last verified
Oct 2026
First submitted
14 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study team does not currently plan to share IPD with other researchers due to concerns regarding patient confidentiality, participant privacy, and the potential risk of re-identification. Access to study data will be restricted to researchers in the Pharmacometrics for Health Sciences Research Group, Faculty of Pharmaceutical Sciences, Chulalongkorn University, and individuals authorized in writing by the researchers. Any future proposal to share IPD will be reviewed for consistency with the informed consent, ethics committee requirements, institutional policies, and applicable laws.

Publications

  • Chaijamorn W, Charoensareerat T, Rungkitwattanakul D, Phunpon S, Sathienluckana T, Srisawat N, Pattharachayakul S. Levetiracetam dosing in patients receiving continuous renal replacement therapy. Epilepsia. 2021 Sep;62(9):2151-2158. doi: 10.1111/epi.16971. Epub 2021 Jul 11.

    PubMed 34247386
  • Chappell K, Kimmons LA, Haller JT, Canada RB, He H, Hudson JQ. Levetiracetam pharmacokinetics in critically ill patients undergoing renal replacement therapy. J Crit Care. 2021 Feb;61:216-220. doi: 10.1016/j.jcrc.2020.10.032. Epub 2020 Nov 2.

    PubMed 33217623
  • Kalaria SN, Armahizer M, McCarthy P, Badjatia N, Gobburu JV, Gopalakrishnan M. A Practice-Based, Clinical Pharmacokinetic Study to Inform Levetiracetam Dosing in Critically Ill Patients Undergoing Continuous Venovenous Hemofiltration (PADRE-01). Clin Transl Sci. 2020 Sep;13(5):950-959. doi: 10.1111/cts.12782. Epub 2020 Apr 3.

    PubMed 32223067
  • Louie JM, Raphael KL, Barker B. Levetiracetam Use With Continuous Renal Replacement Therapy. Ann Pharmacother. 2015 Sep;49(9):1079-80. doi: 10.1177/1060028015591845. Epub 2015 Jun 23. No abstract available.

    PubMed 26104053
  • Van Matre ET, Mueller SW, Fish DN, MacLaren R, Cava LF, Neumann RT, Kiser TH. Levetiracetam Pharmacokinetics in a Patient with Intracranial Hemorrhage Undergoing Continuous Veno-Venous Hemofiltration. Am J Case Rep. 2017 Apr 27;18:458-462. doi: 10.12659/ajcr.902709.

    PubMed 28446744
  • Nei SD, Wittwer ED, Kashani KB, Frazee EN. Levetiracetam Pharmacokinetics in a Patient Receiving Continuous Venovenous Hemofiltration and Venoarterial Extracorporeal Membrane Oxygenation. Pharmacotherapy. 2015 Aug;35(8):e127-30. doi: 10.1002/phar.1615. Epub 2015 Aug 3.

    PubMed 26242293
  • New AM, Nei SD, Kashani KB, Rabinstein AA, Frazee EN. Levetiracetam Pharmacokinetics During Continuous Venovenous Hemofiltration and Acute Liver Dysfunction. Neurocrit Care. 2016 Aug;25(1):141-4. doi: 10.1007/s12028-016-0242-1.

    PubMed 26800696
  • le Noble JL, Foudraine NA, Kornips FH, van Dam DG, Neef C, Janssen PK. Extracorporeal Clearance of Levetiracetam During Continuous Venovenous Hemofiltration in a Critically Ill Patient and New Dosing Recommendation. J Clin Pharmacol. 2017 Apr;57(4):536-537. doi: 10.1002/jcph.844. Epub 2016 Nov 21. No abstract available.

    PubMed 27868207
  • Brockmoller J, Thomsen T, Wittstock M, Coupez R, Lochs H, Roots I. Pharmacokinetics of levetiracetam in patients with moderate to severe liver cirrhosis (Child-Pugh classes A, B, and C): characterization by dynamic liver function tests. Clin Pharmacol Ther. 2005 Jun;77(6):529-41. doi: 10.1016/j.clpt.2005.02.003.

    PubMed 15961984

Questions about this trial

What is this clinical trial studying?

An observational study of Continuous Renal Replacement Therapy (CRRT) and Pharmacokinetics, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Supanat Khueankaew, PharmD (+6622188403, supanat.khnat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probability of target attainment for simulated levetiracetam dosing regimens (time frame: At completion of population pharmacokinetic model development and Monte Carlo simulations (approximately 23 months after study start).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07918833, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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