Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
NCT07918833, Recruiting, Chulalongkorn University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy | ClinicalTrials.gov |
| NCT number | NCT07918833 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 15 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Chulalongkorn University | ClinicalTrials.gov |
| Conditions | Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics, Levetiracetam, Critical Illness | ClinicalTrials.gov |
| Interventions | Levetiracetam | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Probability of target attainment for simulated levetiracetam dosing regimens | 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. | ClinicalTrials.gov |
| Secondary | Levetiracetam plasma exposure based on the area under the concentration-time curve (AUC) | 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. | ClinicalTrials.gov |
| Secondary | Volume of distribution of levetiracetam | 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. | ClinicalTrials.gov |
| Secondary | Total clearance of levetiracetam | 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. | ClinicalTrials.gov |
| Secondary | Levetiracetam sieving and saturation coefficients during continuous renal replacement therapy (CRRT) | 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). | ClinicalTrials.gov |
| Secondary | Levetiracetam clearance by CRRT | 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. | ClinicalTrials.gov |
| Secondary | Renal clearance of levetiracetam | 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. | ClinicalTrials.gov |
| Secondary | Non-renal clearance of levetiracetam | 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. | ClinicalTrials.gov |
| Secondary | Population typical value of levetiracetam clearance | 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. | ClinicalTrials.gov |
| Secondary | Population typical value of levetiracetam volume of distribution | 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. | ClinicalTrials.gov |
| Secondary | Population typical value of CRRT-mediated levetiracetam clearance | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 9
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)