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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

Tracking Information
First Submitted Date  ICMJE July 25, 2018
First Posted Date  ICMJE August 16, 2018
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE November 20, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2018)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03632915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Antiepileptics in Patients on CRRT
Official Title  ICMJE Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Kidney Injury
  • Renal Insufficiency
  • Renal Failure
  • Pharmacokinetics
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shamir N Kalaria, Pharm.D. 4107061480 skalaria@umaryland.edu
Contact: Michael Armahizer, Pharm.D. 4106285644 michaelarmahizer@umm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03632915
Other Study ID Numbers  ICMJE HP-00066222
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Neeraj Badjatia, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Center for Translational Medicine (CTM), University of Maryland School of Pharmacy
Investigators  ICMJE
Principal Investigator: Neeraj Badjatia, MD University of Maryland, College Park
PRS Account University of Maryland, Baltimore
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP