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Assessing Renal Function in Patients With an Antibiotic Laden Spacer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01683734
Recruitment Status : Recruiting
First Posted : September 12, 2012
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):
Central DuPage Hospital

Brief Summary:
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.

Condition or disease
Infected Total Hip or Knee Arthroplasty

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty
Study Start Date : May 2012
Estimated Primary Completion Date : December 2019

Resource links provided by the National Library of Medicine

Renal Function Observation

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01683734

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Contact: Stefanie Miller, BS 630-933-6254
Contact: Judy Guerreiro, RN 630-933-2941

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United States, Illinois
RUSH University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Principal Investigator: Scott Sporer, MD         
Sponsors and Collaborators
Central DuPage Hospital
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Principal Investigator: Scott Sporer, MD RUSH University Medical Center; Central DuPage Hospital

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Responsible Party: Central DuPage Hospital Identifier: NCT01683734     History of Changes
Other Study ID Numbers: Nephro11-021-1
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents