Assessing Renal Function in Patients With an Antibiotic Laden Spacer

February 3, 2015 updated by: Central DuPage Hospital

Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty

The purpose of this study is to monitor the renal function of patients who have an antibiotic laden spacer in place to treat an infected hip or knee arthroplasty.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
      • Winfield, Illinois, United States, 60190
        • Recruiting
        • Central DuPage Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection surgery

Description

Inclusion Criteria:

  1. All patients undergoing a hip or knee resection arthroplasty by the primary investigator
  2. Ages 18+
  3. Ability to adhere to follow up schedule

Exclusion Criteria:

  1. Unable to give informed consent
  2. Age <18
  3. Previous history of infected Total Knee Arthroplasty or Total Hip Arthroplasty
  4. History of renal failure or impaired renal function
  5. Allergies to aminoglycosides or Vancomycin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Renal Function Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of acute renal insufficiency or acute renal failure measured by changes in laboratory values assessing renal function
Time Frame: subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks
subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central DuPage Hospital

Investigators

  • Principal Investigator: Scott Sporer, MD, RUSH University Medical Center; Central DuPage Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Nephro11-021-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infected Total Hip or Knee Arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe