Integrative HD Vascular Access Assessment

NCT03140345 | Unknown

• 1 other identifier: TCMG/NTUNHS105-B- 12-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this two-year study is to explore the relationship among function of HVA, nail-fold capillaries and TCM constitutions based on hybridizing data mining techniques. This study will not only improve our understanding on the expressions of function of HVA, nailfold capillaries and tendency of TCM patterns, but also demonstrate the fundamental knowledge of a novel healthcare model on hemodialysis vascular access.

Conditions

Renal Dialysis; Integrative Medicine; Hemodialysis Access Failure

Keywords

Hemodialysis; Microcirculation; Traditional Chinese Medicine; Hemodialysis vascular access

Outcome Measures

Primary Outcomes (1)

• Patency of hemodialysis vascular access

  Patency of hemodialysis vascular access is defined as 1) the interval from the time of access placement to the time of access abandonment, any patency reestablish intervention, or create new access; and 2) the number of hemodialysis vascular access dysfunction events. The time of access placement and the time of the intervention, as well as number of hemodialysis vascular access dysfunction events will be retrieved from medical records. The interval from the time of access placement to the intervention will be calculated in days.

  through study completion, an average of 2 year

Secondary Outcomes (5)

• Nail-fold blood flow velocity of the hands of the paticipants

  2 years

• Total vessel density of nail-fold capillary in the hands of participants.

  2 years

• Diameter of nail-fold capillary in the hands of participants.

  2 years

• Abnormalities of nail-fold capillary in the hands of participants.

  2 years

• Distribution of the traditional Chinese medicine constitution patterns of HD patients

  8 months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult ESRD patients having HD in two hospitals in the north of Taiwan

You may qualify if:

• having ESRD and needing hemodialysis three times weekly, having undergone hemodialysis ≥ 3 months, speaking Chinese or Taiwanese, and agreeing for data to be collected and stored in a database for analysis

You may not qualify if:

• life expectancy ≤ 3 months, having a malignant tumor, having unstable hemodynamics, having had a cerebrovascular accident, having acute heart failure, having acute bronchitis with acute exacerbation, or having had a severe infection in the last three months

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 112, Taiwan

RECRUITING

Related Publications (4)

• Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.

  PMID: 24183112 BACKGROUND

• Ocak G, Rotmans JI, Vossen CY, Rosendaal FR, Krediet RT, Boeschoten EW, Dekker FW, Verduijn M. Type of arteriovenous vascular access and association with patency and mortality. BMC Nephrol. 2013 Apr 4;14:79. doi: 10.1186/1471-2369-14-79.

  PMID: 23557085 BACKGROUND

• Wu CC, Zhang G, Huang TC, Lin KP. Red blood cell velocity measurements of complete capillary in finger nail-fold using optical flow estimation. Microvasc Res. 2009 Dec;78(3):319-24. doi: 10.1016/j.mvr.2009.07.002. Epub 2009 Jul 30.

  PMID: 19647002 BACKGROUND

• Wu CC, Lin WC, Zhang G, Chang CW, Liu RS, Lin KP, Huang TC. Accuracy evaluation of RBC velocity measurement in nail-fold capillaries. Microvasc Res. 2011 May;81(3):252-60. doi: 10.1016/j.mvr.2011.01.003. Epub 2011 Jan 19.

  PMID: 21255589 BACKGROUND

Study Officials

• Hui-Chu Chiang

  College of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Chu Chiang, PI

CONTACT

+886-2-28227101; huichu@ntunhs.edu.tw

Wen-Chen Lin, Co-PI

CONTACT

+886-3-2654846; lin_wenchen@cycu.org.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: May 4, 2017
• Study Start: June 7, 2017
• Primary Completion: October 1, 2019
• Study Completion: November 30, 2019
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)