Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement

November 20, 2014 updated by: University of Chicago
The purpose of this study is to compare the difference in thrombosis as a result of internal jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ catheters verses PICC lines.

Study Overview

Status

Completed

Conditions

Detailed Description

In a cohort of patients from Sept 1, 2010 until December 31, 2011 with chronic kidney disease (CKD) has shown that the incidence of IJ thrombosis after short term catheter access occurred in only 1/26 subjects or 4%. The current study is being done to compare this experience with the incidence of thrombosis from PICC lines. A secondary aim will be to determine if variables such as level of renal function, prior history of thrombosis or atherosclerosis contribute to the risk of thrombosis when PICC lines are placed. This data will provide the first comparison of the incidence of thrombotic complications from short term IJ catheter access versus PICC lines.

Study Type

Observational

Enrollment (Actual)

1424

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, 60637
        • The University of Chicago

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

Subjects who had a PICC line placed at the University of Chicago by the procedure service between September 1, 2010 and December 31, 2011

Description

Inclusion Criteria:

  • subjects who had a PICC line placed at the University of Chicago between September 1, 2010 and December 31, 2011

Exclusion Criteria:

  • subjects under the age of 18

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
Thrombosis
incidence of thrombosis in subjects who had PICC line placement
No Thrombosis
no incidence of thrombosis in subjects who had PICC line placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Thrombosis
Time Frame: 15 months
To calculate the incidence of deep venous thrombosis from PICC lines in patients
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Risk Factor Association with Risk of Thrombosis from PICC or IJ access
Time Frame: 15 months
To evaluate if factors, known to be associated with thrombosis and atherosclerosis, are associated with the risk of thrombosis from PICC or IJ access. These factors include: renal failure, diabetes, hypertension, cancer, transplant, gender, age or the indication for the access, including antibiotics or chemotherapy.
15 months

Collaborators and Investigators

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

Sponsor

University of Chicago

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

October 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB12-1889

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.

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