Pharmacokinetics of Antiepileptics in Patients on CRRT

Completed

• Conditions: Acute Kidney Injury; Renal Insufficiency; Renal Failure; Pharmacokinetics
• Interventions: Drug: Levetiracetam; Drug: Lacosamide; Drug: Phenytoin; Drug: Phenobarbital; Drug: Ketamine; Drug: Valproic Acid

• Registration Number: NCT03632915
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-20
• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-08-12
• Study First Posted: 2018-08-16
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No study intervention	Levetiracetam	No study intervention
No study intervention	Lacosamide	No study intervention
No study intervention	Phenytoin	No study intervention
No study intervention	Phenobarbital	No study intervention
No study intervention	Ketamine	No study intervention
No study intervention	Valproic Acid	No study intervention

Primary Outcome Measures

Name	Time	Method
Determination of drug specific sieving coefficient (SC)	Single Dosing Interval - 12 hours	SC is a measure of a filter efficiency in clearing drugs and solute. SC will be calculated using pre-filter and effluent concentrations
Influence of renal replacement therapy on drug exposure (AUC of plasma concentration levels)	Single Dosing Interval - 12 hours	Simultaneous 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 clearance	Single Dosing Interval - 12 hours	Simultaneous 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.

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States