Pharmacokinetics of Antiepileptics in Patients on CRRT

NCT ID: NCT03632915

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury Renal Insufficiency Renal Failure Pharmacokinetics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No study intervention

No study intervention

Levetiracetam

Intervention Type DRUG

Standard of care

Lacosamide

Intervention Type DRUG

Standard of care

Phenytoin

Intervention Type DRUG

Standard of care

Phenobarbital

Intervention Type DRUG

Standard of care

Ketamine

Intervention Type DRUG

Standard of care

Valproic Acid

Intervention Type DRUG

Standard of care

Interventions

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Levetiracetam

Standard of care

Intervention Type DRUG

Lacosamide

Standard of care

Intervention Type DRUG

Phenytoin

Standard of care

Intervention Type DRUG

Phenobarbital

Standard of care

Intervention Type DRUG

Ketamine

Standard of care

Intervention Type DRUG

Valproic Acid

Standard of care

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Neeraj Badjatia

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neeraj Badjatia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00066222

Identifier Type: -

Identifier Source: org_study_id

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