Acute Kidney InjuryPADRENCT03632915
Pharmacokinetics of Antiepileptics in Patients on CRRT
An observational study of Acute Kidney Injury and Renal Insufficiency, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury, Renal Insufficiency, Renal Failure
- What is being tested?
- Levetiracetam, Lacosamide and Phenytoin
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing CRRT who are also being treated with an antiepileptic drug
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Age < 18
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
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.
- Being tested
- Levetiracetam, Lacosamide, Phenytoin, Phenobarbital, Ketamine
- Keywords
- Antiepileptics, Continuous Renal Replacement Therapy
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Standard of care
LacosamideDrug
Standard of care
PhenytoinDrug
Standard of care
PhenobarbitalDrug
Standard of care
KetamineDrug
Standard of care
Valproic AcidDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| No study intervention | No study intervention Receives: Drug: Levetiracetam; Drug: Lacosamide; Drug: Phenytoin; Drug: Phenobarbital; Drug: Ketamine; Drug: Valproic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of renal replacement therapy on drug exposure (AUC of plasma concentration levels)
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.
Measured: Single Dosing Interval - 12 hours
Influence of renal replacement therapy on drug clearance
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.
Measured: Single Dosing Interval - 12 hours
Determination of drug specific sieving coefficient (SC)
SC is a measure of a filter efficiency in clearing drugs and solute. SC will be calculated using pre-filter and effluent concentrations
Measured: Single Dosing Interval - 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start20 Nov 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neeraj Badjatia, University of Maryland, Baltimore
- Investigators
- Neeraj Badjatia, MD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632915
- Sponsor's protocol ID
- HP-00066222
- Acronym
- PADRE
- Status last verified
- Sep 2021
- First submitted
- 25 Jul 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT03632915
- Acronym / sponsor ID
- PADRE / HP-00066222
- Keywords
- Antiepileptics, Continuous Renal Replacement Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No study intervention | – | Drug: Levetiracetam, Drug: Lacosamide, Drug: Phenytoin, Drug: Phenobarbital, Drug: Ketamine, Drug: Valproic AcidNo study intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing CRRT who are also being treated with an antiepileptic drug
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Age < 18
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamStandard of care | Drug | No study intervention |
| LacosamideStandard of care | Drug | No study intervention |
| PhenytoinStandard of care | Drug | No study intervention |
| PhenobarbitalStandard of care | Drug | No study intervention |
| KetamineStandard of care | Drug | No study intervention |
| Valproic AcidStandard of care | Drug | No study intervention |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neeraj Badjatia, MD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Renal Insufficiency, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of renal replacement therapy on drug exposure (AUC of plasma concentration levels) (time frame: Single Dosing Interval - 12 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.