Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Continuous Renal Replacement Therapy (CRRT) · Pharmacokinetics · Levetiracetam · Critical Illness
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 15 Estimado
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Acerca de la investigación
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.
¿Quién podría participar?
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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.
Población del estudio
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.
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- No informado
- Enmascaramiento
- No informado
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Probability of target attainment for simulated levetiracetam dosing regimens
Plazo: 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.
Medidas secundarias
Levetiracetam plasma exposure based on the area under the concentration-time curve (AUC)
Plazo: 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
Plazo: 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
Plazo: 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)
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
King Chulalongkorn Memorial HospitalPathum Wan, Bangkok, ThailandReclutando
Equipo y fechas
- Patrocinador principal
- Chulalongkorn University
- Inicio del estudio
- 6 nov 2026 Real
- Finalización primaria
- 30 sept 2027 Estimado
- Finalización del estudio
- 30 jun 2028 Estimado
- Primera publicación
- 5 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026