NCT04399564

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

7 days

First QC Date

May 15, 2020

Last Update Submit

March 16, 2021

Conditions

Stenosis of Arteriovenous Dialysis Fistula

Keywords

central vein stenosistemporary hemodialysis catheterslong term hemodialysis catheter

Outcome Measures

Primary Outcomes (1)

  • central vein stenosis

    use of venography as the primary imaging modality for vein mapping

    8 weeks after temporary or long-term hemodialysis catheter

Secondary Outcomes (2)

  • time of infection

    8 weeks

  • catheter unobstructed degree

    8 weeks

Study Arms (2)

temporary hemodialysis catheters

ACTIVE COMPARATOR

one arm-temporary hemodialysis catheter

Device: temporary hemodialysis catheters

long-term hemodialysis catheters

EXPERIMENTAL

another arm-long term hemodialysis catheter

Device: long-term hemodialysis catheters

Interventions

temporary hemodialysis cathetersDEVICE

Vascular access using temporary vs.long-term hemodialysis catheters

temporary hemodialysis catheters
long-term hemodialysis cathetersDEVICE

long-term hemodialysis catheters

long-term hemodialysis catheters

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • need to receive long-term hemodialysis no arteriovenous shunts or immature arteriovenous shunts

You may not qualify if:

  • Uremia with heart failure or lung function failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hui Min Jin, MD

    Shanghai Pudong Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Min Jin, MD

CONTACT

13917232915hmjgli@163.com

Xiu Hong Yang, MD

CONTACT

1831707089718317070897@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 22, 2020

Study Start

May 25, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share