Temporary vs.Long Term Hemodialysis Catheter on Central V... | NCT04399564

Studies
Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis

NCT04399564

Sponsor

Shanghai Pudong Hospital

Status

Unknown status

Last Update Posted

Mar 17, 2021Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Stenosis of Arteriovenous Dialysis Fistula

Interventions

temporary hemodialysis catheters
long-term hemodialysis catheters

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2021Estimated

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Jun 1, 2021Estimated

First Submitted Date

May 15, 2020

First Submission Date that Met QC Criteria

May 19, 2020

First Posted Date

May 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2021

Last Update Posted Date

Mar 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
temporary hemodialysis catheters	Device	Vascular access using temporary vs.long-term hemodialysis catheters	temporary hemodialysis catheters

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hui Min Jin, MD	Contact	13917232915		hmjgli@163.com
Xiu Hong Yang, MD	Contact	18317070897		18317070897@163.com

Overall Officials

Name	Affiliation	Role
Hui Min Jin, MD	Shanghai Pudong Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided