Assessing Renal Function in Patients With an Antibiotic L... | NCT01683734

Studies
Assessing Renal Function in Patients With an Antibiotic Laden Spacer

NCT01683734

Sponsor

Central DuPage Hospital

Status

Unknown status

Last Update Posted

Feb 4, 2015Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Infected Total Hip or Knee Arthroplasty

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Dec 2019Estimated

Completion Date

Not provided

First Submitted Date

Aug 28, 2012

First Submission Date that Met QC Criteria

Sep 10, 2012

First Posted Date

Sep 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2015

Last Update Posted Date

Feb 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Label	Type	Description	Intervention Names
Renal Function Observation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefanie Miller, BS	Contact	630-933-6254		Stefanie.Miller@CadenceHealth.org
Judy Guerreiro, RN	Contact	630-933-2941		Judy.Guerreiro@CadenceHealth.org

Overall Officials

Name	Affiliation	Role
Scott Sporer, MD	RUSH University Medical Center; Central DuPage Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RUSH University Medical Center	Recruiting	Chicago	Illinois	60612	United States