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.
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
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Levetiracetam (DRUG)Standard of care
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Lacosamide (DRUG)Standard of care
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Phenytoin (DRUG)Standard of care
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Phenobarbital (DRUG)Standard of care
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Ketamine (DRUG)Standard of care
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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
Lead Sponsor:
University of Maryland, Baltimore
Responsible Party:
N/A
Location
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
* 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.
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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