The Relationship Between the Flow of Arteriovenous Fistul... | NCT02747966

Studies
The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients

NCT02747966

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Apr 26, 2016Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Complication of Hemodialysis

Interventions

Not provided

Countries

China

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

May 21, 2015

First Submission Date that Met QC Criteria

Apr 21, 2016

First Posted Date

Apr 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

Apr 25, 2016

Last Update Posted Date

Apr 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at various age range and both sexes are recruited to observe their access flow, access recirculation and cardiac function and assess their relationship.

Detailed Description

All patients recruited who met the inclusion criteria were investigated access flow, access recirculation and cardiac function(including cardiac output,cardiac index,central blood volume,et al).Measurement time is the beginning of HD session (first 30min to 1 hr),Middle of HD session (optional),and the end of the HD session (1hr to 30 min prior to end of session). The follow-up duration is 6 months and 12 months.Repeat the assessment at the above time points.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to access the chang of the fistula blood flow in HD patients using Ultrasound Dilution method		Change of the fistula blood flow from baseline to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Changes of the Cardiac Index (CI) during the course of hemodialysis therapy		from baseline to 6 months
Changes of the Oxygen delivery ( Adequacy of hemoglobin level to Epoetin) during the course of hemodialysis therapy		from baseline to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergo HD with native AVF
AF of AVF between 300ml/min and 1800ml/min

Exclusion Criteria:

Patients whose AVF developed Access Recirculation (AR) which cannot be resolved at the time of measurement
Patients developed access or systemic infection during the study period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All eligible participants are recruited according the inclusion and exclusion criteria.Their basis data are documented and the central hemodynamic condition are assess cross-sectionally and longitudinally.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xueqing Yu, MD	Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The 1st Affiliated Hospital, Sun Yet-sen University		Guangzhou	Guangdong	510080	China