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Pharmacokinetics of Antiepileptics in Patients on CRRT (PADRE)

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ClinicalTrials.gov Identifier: NCT03632915
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Center for Translational Medicine (CTM), University of Maryland School of Pharmacy
Information provided by (Responsible Party):
Neeraj Badjatia, University of Maryland, Baltimore

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
Acute Kidney Injury Renal Insufficiency Renal Failure Pharmacokinetics Drug: Levetiracetam Drug: Lacosamide Drug: Phenytoin Drug: Phenobarbital Drug: Ketamine Drug: Valproic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Intervention Details:
  • 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


Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632915


Contacts
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Contact: Shamir N Kalaria, Pharm.D. 4107061480 skalaria@umaryland.edu
Contact: Michael Armahizer, Pharm.D. 4106285644 michaelarmahizer@umm.edu

Locations
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United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Shamir N. Kalaria, Pharm.D.    410-628-5644    shamir.kalaria@umm.edu   
Sponsors and Collaborators
University of Maryland, Baltimore
Center for Translational Medicine (CTM), University of Maryland School of Pharmacy
Investigators
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Principal Investigator: Neeraj Badjatia, MD University of Maryland, College Park

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Responsible Party: Neeraj Badjatia, Professor of Neurology, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03632915     History of Changes
Other Study ID Numbers: HP-00066222
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Maryland, Baltimore:
Antiepileptics
Continuous Renal Replacement Therapy
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Lacosamide
Phenytoin
Ketamine
Levetiracetam
Valproic Acid
Phenobarbital
Anticonvulsants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nootropic Agents
Enzyme Inhibitors
GABA Agents
Antimanic Agents
Tranquilizing Agents
Psychotropic Drugs