Clinical trial NCT06765577: Prognostic Value of Finger Blood Pressure in Arteriovenous Fistula Care
Official title: Prognostic Value of Finger Blood Pressure in Arteriovenous Fistula Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
End-Stage Kidney Disease
Dialysis Access Dysfunction
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between AVF maturation and changes in Finger Blood Pressure measurements at baseline and immediately post-op
timeFrame: Within 24 hours
Secondary outcomes:
measure: Correlation between AVF maturation and changes in Finger Blood Pressure measurements across other timepoints
timeFrame: Until 6 weeks post-operation
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
state: SG
Study officials:
affiliation: Singapore General Hospital
name: Tze Tec Chong, MBBS, RPVI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.