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Pharmacokinetics of Antiepileptics in Patients on CRRT

Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03632915
Acronym
PADRE
Enrollment
18
Registered
2018-08-16
Start date
2017-11-20
Completion date
2019-12-31
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Pharmacokinetics, Renal Failure, Renal Insufficiency

Keywords

Antiepileptics, Continuous Renal Replacement Therapy

Brief summary

The purpose of the study is to measure levels of any of the following AEDs (levetiracetam, phenobarbital, phenytoin, ketamine, valproic acid, lacosamide) in blood and effluent on critically ill patients receiving CRRT in order to characterize drug pharmacokinetics and optimize dosing strategies in patients on CRRT.

Interventions

DRUGLevetiracetam

Standard of care

DRUGLacosamide

Standard of care

DRUGPhenytoin

Standard of care

DRUGPhenobarbital

Standard of care

DRUGKetamine

Standard of care

DRUGValproic Acid

Standard of care

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Expected to be on CRRT and receive any of the following for more than 24 hrs * Expected to survive for more than 24 hrs * Achievement of steady state drug concentrations prior to study enrollment

Exclusion criteria

* Pregnancy * Age \< 18 * Prisoner

Design outcomes

Primary

MeasureTime frameDescription
Influence of renal replacement therapy on drug exposure (AUC of plasma concentration levels)Single Dosing Interval - 12 hoursSimultaneous samples will be taken from pre-filter, post-filter, and effluent sampling ports before dose administration, after the completion of the infusion or 1 hours post oral dose, and 6 additional time points post-infusion or post oral administration.
Influence of renal replacement therapy on drug clearanceSingle Dosing Interval - 12 hoursSimultaneous samples will be taken from pre-filter, post-filter, and effluent sampling ports before dose administration, after the completion of the infusion or 1 hours post oral dose, and 6 additional time points post-infusion or post oral administration.
Determination of drug specific sieving coefficient (SC)Single Dosing Interval - 12 hoursSC is a measure of a filter efficiency in clearing drugs and solute. SC will be calculated using pre-filter and effluent concentrations

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026