Pharmacokinetics of Antiepileptics in Patients on CRRT
PADRE
1 other identifier
observational
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2017
CompletedFirst Submitted
Initial submission to the registry
July 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedOctober 5, 2021
September 1, 2021
2.1 years
July 25, 2018
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
No study intervention
No study intervention
Interventions
Eligibility Criteria
All patients undergoing CRRT who are also being treated with an antiepileptic drug
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Age \< 18
- Prisoner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neeraj Badjatia, MD
University of Maryland, College Park
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 16, 2018
Study Start
November 20, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
October 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share