Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Continuous Renal Replacement Therapy (CRRT) · Pharmacokinetics · Levetiracetam · Critical Illness
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 15 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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.
Understand screeningTreatment, groups and participation
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- Assignment
- Not reported
- Masking
- Not reported
Critically Ill Adult Patients Receiving Levetiracetam During CRRT
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 DRUG
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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).
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.
Secondary measures
Levetiracetam plasma exposure based on the area under the concentration-time curve (AUC)
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
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.
Volume of distribution of levetiracetam
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
The volume of distribution of levetiracetam will be estimated using noncompartmental pharmacokinetic analysis based on the administered dose, elimination rate constant, and AUC.
Total clearance of levetiracetam
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
Total clearance of levetiracetam will be estimated using noncompartmental pharmacokinetic analysis based on the administered dose and AUC.
Levetiracetam sieving and saturation coefficients during continuous renal replacement therapy (CRRT)
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
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).
Levetiracetam clearance by CRRT
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
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.
Renal clearance of levetiracetam
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
Renal clearance of levetiracetam will be calculated based on urinary levetiracetam concentrations, urine volume, and plasma levetiracetam concentrations.
Non-renal clearance of levetiracetam
Time frame: From predose (0 hours) to pre-next dose (e.g., 12 hours) after initiation of levetiracetam administration.
Non-renal clearance of levetiracetam will be estimated from total systemic drug clearance after accounting for renal and CRRT clearance.
Population typical value of levetiracetam clearance
Time frame: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).
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.
Population typical value of levetiracetam volume of distribution
Time frame: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).
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.
Population typical value of CRRT-mediated levetiracetam clearance
Time frame: Following completion of pharmacokinetic data collection and population pharmacokinetic analysis (approximately 23 months after study start).
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
King Chulalongkorn Memorial HospitalPathum Wan, Bangkok, ThailandRecruiting
Study team and timeline
- Lead sponsor
- Chulalongkorn University
- Study start
- Nov 6, 2026 Actual
- Primary completion
- Sep 30, 2027 Estimated
- Study completion
- Jun 30, 2028 Estimated
- First posted
- Nov 5, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026