- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06765577
Prognostic Value of Finger Blood Pressure in Arteriovenous Fistula Care
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
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SG
-
Singapore, SG, Singapore, 169856
- Singapore General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Tze Tec Chong, MBBS, RPVI, Singapore General Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Pathological Conditions, Anatomical
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Renal Insufficiency, Chronic
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Kidney Diseases
- Kidney Failure, Chronic
- Fistula
- Arteriovenous Fistula
Other Study ID Numbers
- 2019/2459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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