Dialysis Catheter Comparative Clinical Trial
A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis
1 other identifier
interventional
599
1 country
14
Brief Summary
The purpose of this clinical trial is to compare the longevity of two dialysis catheters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 5, 2007
CompletedFirst Posted
Study publicly available on registry
September 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
January 7, 2013
CompletedJanuary 7, 2013
January 1, 2013
3.9 years
September 5, 2007
August 30, 2012
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
30 days
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
60 days
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
245 days
Secondary Outcomes (5)
Inadequate Flow Rates Requiring Surgical/Radiological Intervention
35 weeks
Average Number of Line Reversals Per Subject
35 Weeks
Frequency of Clinician Interventions for Catheter Malfunction and Infection
35 Weeks
Primary Failure Rate
First dialysis session with study catheter
Reliability of the Catheter
35 Weeks
Study Arms (2)
1
ACTIVE COMPARATORsymmetric tip catheter
2
ACTIVE COMPARATORconventional split-tip catheter
Interventions
Eligibility Criteria
You may qualify if:
- Subject must be 18 years of age or older.
- Subject must meet labeled indication for hemodialysis.
- Subject must have End Stage Renal Disease (ESRD).
- Subject must have a patent right or left internal jugular vein.
- Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks.
- Subject must give written informed consent.
You may not qualify if:
- Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study.
- Subjects with active infection at the time of study enrollment.
- Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
- Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
- Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period.
- Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason.
- Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study.
- Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Nephrology Associates, P.C.
Birmingham, Alabama, 35211, United States
Southwest Kidney Institute
Phoenix, Arizona, 85004, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
SUNY Stony Brook Medical Center
Stony Brook, New York, 11794, United States
Eastern Nephrology Associates
Greenville, North Carolina, 27834, United States
Eastern Nephrology Associates
New Bern, North Carolina, 28562, United States
Boice-Willis Clinic
Rocky Mount, North Carolina, 27804, United States
Dialysis Access Group of Wake Forest University, LLC
Winston-Salem, North Carolina, 27101, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Nephrology Associates - Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Columbia Nephrology Associates
Columbia, South Carolina, 29203, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Klemens B. Meyer
- Organization
- Tufts Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Klemens B Meyer, MD
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2007
First Posted
September 6, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 7, 2013
Results First Posted
January 7, 2013
Record last verified: 2013-01