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OpenTrials
Completed

NCT Number: NCT03632915

Pharmacokinetics of Antiepileptics in Patients on CRRT

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pharmacokinetics Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Standard of care

Lacosamide

Drug

Standard of care

Phenytoin

Drug

Standard of care

Phenobarbital

Drug

Standard of care

ketamine

Drug

Standard of care

Valproic acid

Drug

Standard of care

Primary outcomes

  1. Influence of renal replacement therapy on drug exposure (AUC of plasma concentration levels)

    Time frame: 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.

  2. Influence of renal replacement therapy on drug clearance

    Time frame: 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.

  3. Determination of drug specific sieving coefficient (SC)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Acronym: PADRE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2018
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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