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Assessing Renal Function in Patients With an Antibiotic Laden Spacer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Central DuPage Hospital
Sponsor:
Information provided by (Responsible Party):
Central DuPage Hospital
ClinicalTrials.gov Identifier:
NCT01683734
First received: August 28, 2012
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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
Infected Total Hip or Knee Arthroplasty

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Central DuPage Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Renal Function Observation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683734

Contacts
Contact: Stefanie Miller, BS 630-933-6254 Stefanie.Miller@CadenceHealth.org
Contact: Judy Guerreiro, RN 630-933-2941 Judy.Guerreiro@CadenceHealth.org

Locations
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
Investigators
Principal Investigator: Scott Sporer, MD RUSH University Medical Center; Central DuPage Hospital
  More Information

No publications provided

Responsible Party: Central DuPage Hospital
ClinicalTrials.gov Identifier: NCT01683734     History of Changes
Other Study ID Numbers: Nephro11-021-1
Study First Received: August 28, 2012
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014