Prognostic Value of Finger Blood Pressure in Arteriovenous Fistula Care

NCT06765577 | Completed

• 1 other identifier: 2019/2459
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease; End-Stage Kidney Disease; Dialysis Access Dysfunction

Outcome Measures

Primary Outcomes (1)

• Correlation between AVF maturation and changes in Finger Blood Pressure measurements at baseline and immediately post-op

  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 Outcomes (1)

• Correlation between AVF maturation and changes in Finger Blood Pressure measurements across other timepoints

  Until 6 weeks post-operation

Study Arms (1)

Patients with End Stage Renal Failure undergoing Arteriovenous Fistula Creation

EXPERIMENTAL

Other: Finger Blood Pressure Measurement

Interventions

Finger Blood Pressure Measurement OTHER

Finger Blood Pressure Measurement were taken from three digits: the thumb (F1), the middle finger (F2), and the little finger (F3) from both arms.

Patients with End Stage Renal Failure undergoing Arteriovenous Fistula Creation

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, SG, 169856, Singapore

Location

Related Publications (3)

• McGrogan DG, Maxwell AP, Khawaja AZ, Inston NG. Current tools for prediction of arteriovenous fistula outcomes. Clin Kidney J. 2015 Jun;8(3):282-9. doi: 10.1093/ckj/sfv019. Epub 2015 Apr 2.

  PMID: 26034589 BACKGROUND

• Lee KG, Chong TT, Goh N, Achudan S, Tan YL, Tan RY, Choong HL, Tan CS. Outcomes of arteriovenous fistula creation, effect of preoperative vein mapping and predictors of fistula success in incident haemodialysis patients: A single-centre experience. Nephrology (Carlton). 2017 May;22(5):382-387. doi: 10.1111/nep.12788.

  PMID: 27042772 BACKGROUND

• Alfano G, Fontana F, Cappelli G. Noninvasive Blood Pressure Measurement in Maintenance Hemodialysis Patients: Comparison of Agreement between Oscillometric and Finger-Cuff Methods. Nephron. 2017;136(4):309-317. doi: 10.1159/000457812. Epub 2017 May 4.

  PMID: 28468005 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tze Tec Chong, MBBS, RPVI

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: January 9, 2025
• Study Start: August 5, 2019
• Primary Completion: December 27, 2019
• Study Completion: February 10, 2020
• Last Updated: January 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)