PADRE: Pharmacokinetics of Antiepileptics in Patients on CRRT

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Completed
CT.gov ID
NCT03632915
Collaborator
(none)
18
1
25.3
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Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
18 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Actual Study Start Date :
Nov 20, 2017
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
No study intervention

No study intervention

Drug: Levetiracetam
Standard of care

Drug: Lacosamide
Standard of care

Drug: Phenytoin
Standard of care

Drug: Phenobarbital
Standard of care

Drug: Ketamine
Standard of care

Drug: Valproic Acid
Standard of care

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Medical Center Baltimore Maryland United States 21201

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

  • Principal Investigator: Neeraj Badjatia, MD, University of Maryland, College Park

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neeraj Badjatia, Professor of Neurology, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT03632915
Other Study ID Numbers:
  • HP-00066222
First Posted:
Aug 16, 2018
Last Update Posted:
Oct 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Neeraj Badjatia, Professor of Neurology, University of Maryland, Baltimore
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021