Pharmacokinetics of Antiepileptics in Patients on CRRT

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.

Intervention / Treatment

  • Levetiracetam (DRUG)
    Standard of care
  • Lacosamide (DRUG)
    Standard of care
  • Phenytoin (DRUG)
    Standard of care
  • Phenobarbital (DRUG)
    Standard of care
  • Ketamine (DRUG)
    Standard of care
  • Valproic Acid (DRUG)
    Standard of care

Condition or Disease

  • Acute Kidney Injury
  • Renal Insufficiency
  • Renal Failure
  • Pharmacokinetics

Phase

Study Design

Study type: OBSERVATIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years to 80 Years
Enrollment: 18 (ACTUAL)
Funded by: Other
Time Perspective: Prospective
Observational Model: Cohort

Masking

Clinical Trial Dates

Start date: Nov 20, 2017 ACTUAL
Primary Completion: Dec 31, 2019 ACTUAL
Completion Date: Dec 31, 2019 ACTUAL
Study First Posted: Aug 16, 2018 ACTUAL
Results First Posted: Aug 31, 2020
Last Updated: Sep 27, 2021

Sponsors / Collaborators

Responsible Party: N/A

Participant Groups

  • No study intervention

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 80
Age Groups: Adult / Older Adult
Healthy Volunteers: Yes

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

Primary Outcomes
  • 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.

  • 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.

  • SC is a measure of a filter efficiency in clearing drugs and solute. SC will be calculated using pre-filter and effluent concentrations

More Details

NCT Number: NCT03632915
Acronym: PADRE
Other IDs: HP-00066222
Study URL: https://clinicaltrials.gov/study/NCT03632915
Last updated: Sep 29, 2023