Pharmacokinetics of Antiepileptics in Patients on CRRT

Acute Kidney Injury Clinical Trial

— PADRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632915
• Other study ID #: HP-00066222
• Status: Completed
• Start date: November 20, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Pharmacokinetics
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Levetiracetam
Standard of care
• Lacosamide
Standard of care
• Phenytoin
Standard of care
• Phenobarbital
Standard of care
• Ketamine
Standard of care
• Valproic Acid
Standard of care

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

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