NCT02747966

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

May 21, 2015

Last Update Submit

April 25, 2016

Conditions

Complication of Hemodialysis

Keywords

access flowaccess recirculationcardiac outputcardiac indexhemodialysis

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

Study Officials

  • Xueqing Yu, MD

    Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 21, 2015

First Posted

April 22, 2016

Study Start

April 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 26, 2016

Record last verified: 2016-04

Locations

CN(1)