Use of Arterio-venous Fistula as First Choice for Intrave... | NCT02874391

Studies
Use of Arterio-venous Fistula as First Choice for Intravenous Drug Administration in Kidney Transplant Recipients

NCT02874391

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Jan 20, 2017Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Evaluate the Risks of Using Arteriovenous Fistula as First Choise for Drug Administration

Interventions

Not provided

Countries

France

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Sep 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Aug 17, 2016

First Submission Date that Met QC Criteria

Aug 17, 2016

First Posted Date

Aug 22, 2016Estimated

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

Jan 19, 2017

Last Update Posted Date

Jan 20, 2017Estimated

Description Module

Brief Summary

Use of arteriovenous fistula for IV drug administration is controversial and often prohibited by nephrologists. However, we have been using this method in our department for years now in order to keep the patients 'veins for other fistulas in the future. The aim of this study is to evaluate our practice and maybe provide a justification for a larger multi-center study given the importance of this subject in patients with chronic renal failure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Measure	Description	Time Frame
Evaluate the risk of complications of AV fistula		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years, functional AV fistula, new kidney transplant recipient

Exclusion Criteria:

Prothetic AV fistula, Very recent AV fistula of less than 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Kidney transplant recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christelle Roux	Contact			Christelle.Roux@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Christelle Roux	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Angers	Recruiting	Angers			France

Label	Type	Description	Intervention Names
AV fistula group
Control group