Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

NCT ID: NCT01507532

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-01-31

Brief Summary

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Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of intravenous ceftazidime pharmacokinetics will be performed in patients undergoing intermittent hemodialysis at Northwestern Memorial Hospital to determine the clearance of ceftazidime in high flux hemodialysis.

Detailed Description

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Conditions

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Renal Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ceftazidime

pharmacokinetic monitoring

Group Type OTHER

pharmacokinetic monitoring

Intervention Type OTHER

pharmacokinetic monitoring

Interventions

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pharmacokinetic monitoring

pharmacokinetic monitoring

Intervention Type OTHER

Other Intervention Names

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Fortaz

Eligibility Criteria

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Inclusion Criteria

* Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours, who have end-stage renal disease and been receiving intermittent hemodialysis for at least 90 days.
* Eligible patients will additionally have either central or peripheral intravenous access, and will already be prescribed ceftazidime per their primary providers.
* Written informed consent in a form approved by Northwestern Memorial Hospital, Northwestern University Institutional Review Board, and Midwestern University Institutional Review Board will be completed by the patient prior to enrollment.

Exclusion Criteria

* Patients that only receive one dose of ceftazidime in total
* Patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Midwestern University

OTHER

Sponsor Role lead

Responsible Party

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Marc Scheetz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc H Scheetz, PharmD

Role: PRINCIPAL_INVESTIGATOR

Midwestern University

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00056702

Identifier Type: -

Identifier Source: org_study_id

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