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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988766
• Other study ID #: IRB12-1889
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: November 20, 2014
• Start date: October 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1424
• Est. completion date: August 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Thrombosis

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Thrombosis	To calculate the incidence of deep venous thrombosis from PICC lines in patients	15 months	Yes
Secondary	Demographic Risk Factor Association with Risk of Thrombosis from PICC or IJ access	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	No