Trials Sponsors Conditions Drugs Pricing

Conditions

Drug Mechanism

Outcome Measures

Primary Outcomes (1)

Composite pharmacokinetic and pharmacodynamic profile of extended-infusion cefepime in CRRT
Each patient will have samples collected on both the first dose and another dose at presumed steady state (dose four, five, or six) to determine the pharmacokinetic and pharmacodynamic profile of extended-infusion cefepime in CRRT. Pharmacokinetic outcomes calculated include half life, volume of distribution, and area under the plasma concentration versus time curve. Sieving and saturation coefficients will also be calculated as appropriate. Time above the minimum inhibitory concentration will be the primary pharmacodynamic outcome studied.
up to 12 months

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Critically ill patients on continuous renal replacement therapy who are being initiated on cefepime 2000 mg IV every 8 hours with a four-hour infusion

You may qualify if:

Age ≥ 18 years

Sponsors & Collaborators

Children's Hospital Medical Center, Cincinnati
Othercollaborator
University of Cincinnati
Otherlead

Biospecimen

Retention: SAMPLES WITH DNA

Samples that are being collected are as follows: serum, continuous renal replacement therapy effluent, and urine (if patient is making urine during sample collection). Drug assays will be performed for each sample and samples will be disposed of after the final analysis is complete. The assays are not interventional and patient care does not change as a result of study enrollment.

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Pharmacist, UC Health, UCMC

Study Record Dates

First Submitted

April 27, 2015

First Posted

June 1, 2015

Study Start

March 2015

Date type not reported

This date has not been verified as actual or estimated.

Pharmacokinetics and Pharmacodynamics of Extended-Infusion Cefepime in Continuous Renal Replacement Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record