Back to resultsTemporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis
Primary Purpose
Stenosis of Arteriovenous Dialysis Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
temporary hemodialysis catheters
long-term hemodialysis catheters
Sponsored by
About this trial
This is an interventional prevention trial for Stenosis of Arteriovenous Dialysis Fistula focused on measuring central vein stenosis, temporary hemodialysis catheters, long term hemodialysis catheter
Eligibility Criteria
Inclusion Criteria:
- need to receive long-term hemodialysis no arteriovenous shunts or immature arteriovenous shunts
Exclusion Criteria:
- Uremia with heart failure or lung function failure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
temporary hemodialysis catheters
long-term hemodialysis catheters
Arm Description
one arm-temporary hemodialysis catheter
another arm-long term hemodialysis catheter
Outcomes
Primary Outcome Measures
central vein stenosis
use of venography as the primary imaging modality for vein mapping
Secondary Outcome Measures
time of infection
infected in temporary or long-term hemodialysis catheters
catheter unobstructed degree
blood flow in hemodialysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04399564
Brief Title
Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis
Official Title
Effect of Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis in Long-term Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pudong Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Vascular access (VA) is the most important for carrying out hemodialysis, yet it may bring in complications and leads to hemodialysis quality decline. This study aimed to explore the impact of vascular access types, including temporary vs.long term hemodialysis catheter on central vein stenosis.
Detailed Description
It is unknown whether central vein stenosis occurs after temporary or long term hemodialysis catheter in long-term hemodialysis patients. this study will aim to explore this question. Study design is randomized, controlled trial. One arm is temporary catheters in the internal jugular vein, and another arm is tunneled cuffed hemodialysis cather. 2*2 is randomly distributed.
The main outcome: central vein stenosis diagnosed by venography. The secondary outcome: the time of infection, and catheter patency. Study period: one year
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis of Arteriovenous Dialysis Fistula
Keywords
central vein stenosis, temporary hemodialysis catheters, long term hemodialysis catheter
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
temporary hemodialysis catheters
Arm Type
Active Comparator
Arm Description
one arm-temporary hemodialysis catheter
Arm Title
long-term hemodialysis catheters
Arm Type
Experimental
Arm Description
another arm-long term hemodialysis catheter
Intervention Type
Device
Intervention Name(s)
temporary hemodialysis catheters
Intervention Description
Vascular access using temporary vs.long-term hemodialysis catheters
Intervention Type
Device
Intervention Name(s)
long-term hemodialysis catheters
Intervention Description
long-term hemodialysis catheters
Primary Outcome Measure Information:
Title
central vein stenosis
Description
use of venography as the primary imaging modality for vein mapping
Time Frame
8 weeks after temporary or long-term hemodialysis catheter
Secondary Outcome Measure Information:
Title
time of infection
Description
infected in temporary or long-term hemodialysis catheters
Time Frame
8 weeks
Title
catheter unobstructed degree
Description
blood flow in hemodialysis
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
need to receive long-term hemodialysis no arteriovenous shunts or immature arteriovenous shunts
Exclusion Criteria:
Uremia with heart failure or lung function failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Min Jin, MD
Phone
13917232915
Email
hmjgli@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiu Hong Yang, MD
Phone
18317070897
Email
18317070897@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Min Jin, MD
Organizational Affiliation
Shanghai Pudong Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis
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