Prognostic Value of Finger Blood Pressure in Arteriovenous Fistula Care

January 3, 2025 updated by: Singapore General Hospital

The goal of this trial is to investigate the prognostic value of monitoring finger blood pressures (FBPs) in predicting the success of surgically created arteriovenous fistula (AVF) for patients with end stage renal disease. The main questions it aims to answer is:

- Can FBPs predict AVF maturation?

Participants will undergo FBP measurements at pre-op, immediately post-op, 4 weeks and 6 weeks post-AVF creation.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SG
      • Singapore, SG, Singapore, 169856
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants has documented Chronic Kidney Disease (CKD), determined by Glomerular Filtration Rate (GFR)
  • Participant is recommended for renal replacement therapy based on clinical assessment of renal function as well as CKD staging, as documented in clinical notes.
  • Haemodialysis was chosen as the most appropriate renal replacement therapy
  • Participant is able to consent to the creation of an AVF in preparation for hemodialysis.
  • Participant is able to adhere to follow-up assessments of AVF maturation, if applicable.

Exclusion Criteria:

  • Subject had a previous AVF and is now undergoing surgery for another AVF creation
  • Subject has amputation distal to AVF
  • Subject is pregnant or planning to conceive
  • Participants is unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with End Stage Renal Failure undergoing Arteriovenous Fistula Creation
Finger Blood Pressure Measurement were taken from three digits: the thumb (F1), the middle finger (F2), and the little finger (F3) from both arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between AVF maturation and changes in Finger Blood Pressure measurements at baseline and immediately post-op
Time Frame: Within 24 hours
To determine whether if there are any pattern in changes observed in FBP pre and post-creation that can be used for correlation to AVF maturation.
Within 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between AVF maturation and changes in Finger Blood Pressure measurements across other timepoints
Time Frame: Until 6 weeks post-operation
To determine whether changes in FBP across time points (pre-op, post-op, 4 weeks and 6 weeks post-op) is correlated with AVF maturation
Until 6 weeks post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tze Tec Chong, MBBS, RPVI, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Actual)

December 27, 2019

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Personal Data Protection Act

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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