PADRE: Pharmacokinetics of Antiepileptics in Patients on CRRT
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
- 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.
- 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
Inclusion Criteria:
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Expected to be on CRRT and receive any of the following for more than 24 hrs
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Expected to survive for more than 24 hrs
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Achievement of steady state drug concentrations prior to study enrollment
Exclusion Criteria:
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Pregnancy
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Age < 18
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Prisoner
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- HP-00066222