An observational study in Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics and Levetiracetam, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Chulalongkorn University · Observational
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 15 is below the median of 140 across 814 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
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The criteria were revised on the registry on Nov 10, 2026. See what changed
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Critically 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.
Drug: Levetiracetam
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.
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.
Time frame: At completion of population pharmacokinetic model development and Monte Carlo simulations (approximately 23 months after study start).
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.
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
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.
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
Total clearance of levetiracetam
Total clearance of levetiracetam will be estimated using noncompartmental pharmacokinetic analysis based on the administered dose and AUC.
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
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).
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
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.
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
Renal clearance of levetiracetam
Renal clearance of levetiracetam will be calculated based on urinary levetiracetam concentrations, urine volume, and plasma levetiracetam concentrations.
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
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.
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
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.
Time frame: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).
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.
Time frame: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).
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.
Time frame: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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