Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis

March 16, 2021 updated by: Shanghai Pudong Hospital

Effect of Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis in Long-term Hemodialysis Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hui Min Jin, MD
  • Phone Number: 13917232915
  • Email: hmjgli@163.com

Study Contact Backup

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: temporary hemodialysis catheters
one arm-temporary hemodialysis catheter
Device: temporary hemodialysis catheters
Vascular access using temporary vs.long-term hemodialysis catheters
Experimental: long-term hemodialysis catheters
another arm-long term hemodialysis catheter
Device: long-term hemodialysis catheters
long-term hemodialysis catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central vein stenosis
Time Frame: 8 weeks after temporary or long-term hemodialysis catheter
use of venography as the primary imaging modality for vein mapping
8 weeks after temporary or long-term hemodialysis catheter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of infection
Time Frame: 8 weeks
infected in temporary or long-term hemodialysis catheters
8 weeks
catheter unobstructed degree
Time Frame: 8 weeks
blood flow in hemodialysis
8 weeks

Collaborators and Investigators

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

Sponsor

Shanghai Pudong Hospital

Investigators

  • Principal Investigator: Hui Min Jin, MD, Shanghai Pudong Hospital

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 (Anticipated)

May 25, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiPudongH3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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