End Stage Renal DiseaseNCT06765577
Prognostic Value of Finger Blood Pressure in Arteriovenous Fistula Care
A study testing Finger Blood Pressure Measurement in people with End Stage Renal Disease and End-Stage Kidney Disease, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- End Stage Renal Disease, End-Stage Kidney Disease, Dialysis Access Dysfunction
- What is being tested?
- Finger Blood Pressure Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Aug 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Finger Blood Pressure Measurement
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger Blood Pressure MeasurementOther
Finger Blood Pressure Measurement were taken from three digits: the thumb (F1), the middle finger (F2), and the little finger (F3) from both arms.
| Study group | Role | What they receive |
|---|---|---|
| Patients with End Stage Renal Failure undergoing Arteriovenous Fistula Creation | Experimental | Not described Receives: Other: Finger Blood Pressure Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours
Secondary outcomes (1)
Correlation between AVF maturation and changes in Finger Blood Pressure measurements across other timepoints
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
Measured: Until 6 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start5 Aug 2019
- Primary completion27 Dec 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tze Tec Chong, MBBS, RPVI, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765577
- Sponsor's protocol ID
- 2019/2459
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal Data Protection Act
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.
PubMed 26034589Lee 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.
PubMed 27042772Alfano 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.
PubMed 28468005
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Finger Blood Pressure in Arteriovenous Fistula Care
- ClinicalTrials.gov ID
- NCT06765577
- Acronym / sponsor ID
- 2019/2459
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with End Stage Renal Failure undergoing Arteriovenous Fistula Creation | Experimental | Other: Finger Blood Pressure Measurement |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger Blood Pressure MeasurementFinger Blood Pressure Measurement were taken from three digits: the thumb (F1), the middle finger (F2), and the little finger (F3) from both arms. | Other | Patients with End Stage Renal Failure undergoing Arteriovenous Fistula Creation |
Primary outcome
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.
1 secondary outcome
Correlation between AVF maturation and changes in Finger Blood Pressure measurements across other timepoints
Time frame: Until 6 weeks post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 26034589McGrogan 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.
- Background: PubMed 27042772Lee 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.
- Background: PubMed 28468005Alfano 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.
- Individual participant dataSharing planned: No. Personal Data Protection Act
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tze Tec Chong, MBBS, RPVI principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger Blood Pressure Measurement in people with End Stage Renal Disease and End-Stage Kidney Disease, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between AVF maturation and changes in Finger Blood Pressure measurements at baseline and immediately post-op (time frame: Within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06765577, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.