Venous PressureNCT07038993
Venous Pressure Monitoring As a Predictor Of High-Flow Access In Prevalent Hemodialysis Patients
An observational study of Venous Pressure and Predictor, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to detect the possibility of using venous pressure as a predictor for high flow access as a simple, non-invasive screening technique in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 28 to 81 years
- Conditions the study is for
- Venous Pressure, Predictor, High Flow Access
- What is being tested?
- Venous Pressure Monitoring and Color Doppler Ultrasound
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Jun 2020
- Phase
- Observational
- 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 28 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A prospective cohort study enrolled 59 chronic hemodialysis patients of both sexes with autogenous arteriovenous fistula (AVF).
Who may be able to join
- Age from 28 to 81.
- Both sexes.
- Patients with the presence of an autogenous arteriovenous fistula (AVF) and a minimum hemodialysis treatment duration of six months.
Who cannot join
- Physical examination revealed signs of AVF outflow stenosis, including localized edema, collateral circulation, hyperpulsatile fistula characteristics, or a positive hand elevation test.
- If ultrasound confirmed AVF stenosis or thrombosis, or angiography identified central venous stenosis or thrombosis in clinically suspected cases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Venous Pressure Monitoring As a Predictor Of High-Flow Access In Prevalent Hemodialysis Patients
This study aimed to detect the possibility of using venous pressure as a predictor for high flow access as a simple, non-invasive screening technique in hemodialysis patients.
Read the detailed description
The patient's vascular access is often referred to as their "lifeline," and without it, the life-sustaining treatment of hemodialysis would not be possible. To maintain access, patency depends on accurate diagnosis and timely, active interventions.
The Kidney Disease Outcomes Quality Initiative (K/DOQI) recommends native arteriovenous fistula (AVF) as the vascular access of choice for hemodialysis due to its longevity, lower complications, and lower mortality rate compared to catheters.
Currently, K/DOQI guidelines suggest that high intra-access pressure may be regarded as a surrogate for arteriovenous fistula (AVF) outflow stenosis. It can be measured using static venous pressure (sVP) or standardized dynamic venous pressure (dVP).
- Conditions
- Venous Pressure, Predictor, High Flow Access, Hemodialysis
- Being tested
- Venous Pressure Monitoring, Color Doppler Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Pressure MonitoringOther
Measurement of venous pressure will be taken at dialysis machine pump speed set at 200ml/min, fistula needle gauge 16.
Color Doppler UltrasoundOther
Arteriovenous fistula (AVF) Access flow (QA) will be obtained using color Doppler ultrasound using the Mindray-M5 ultrasound system. AVF feeding arterial flow will be measured immediately proximal to the fistula. The QA volume will be obtained using the algorithm available on the system, which is based on the mean flow of two measurements.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Chronic hemodialysis patients of both sexes with autogenous arteriovenous fistulas. Receives: Other: Venous Pressure Monitoring; Other: Color Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static venous pressure
Static venous pressure (SVP) were measured with the blood pump deactivated through direct intra-access measurement via the venous outflow cannulation needle. Blood pressure (BP)-adjusted values were calculated using the patient's mean arterial blood pressure (MAP) recorded contemporaneously with venous pressure measurements.
Measured: 6 months post-procedure
Secondary outcomes (3)
Standardized dynamic venous pressure
Standardized dynamic venous pressure (sDVP) measurements were performed with the hemodialysis machine blood pump calibrated to deliver 200 ml/min within five minutes of treatment initiation, utilizing a standardized 16-gauge venous outflow cannulation needle for measurement consistency.
Measured: 6 months post-procedure
Arteriovenous fistula flow
Arteriovenous fistula flow (Qa) was quantified using a Mindray-M5 US system with integrated flow calculation algorithms. Feeding arterial blood velocity and vessel diameter measurements were obtained approximately 2 cm proximal to the fistula anastomosis. Flow calculations were based on the mean of two independent measurements, and patients demonstrating US evidence of stenosis or thrombosis were excluded from further analysis.
Measured: 6 months post-procedure
Urea reduction ratio
Urea reduction ratio (URR) was subsequently calculated as an indicator of hemodialysis treatment adequacy.
Measured: 30 minutes following treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jun 2017
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous PressureStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Hassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038993
- Sponsor's protocol ID
- FMASU MD221/2017
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Venous Pressure Monitoring As a Predictor Of High-Flow Access In Prevalent Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07038993
- Acronym / sponsor ID
- FMASU MD221/2017
- Conditions
- Venous Pressure, Predictor, High Flow Access, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 26 Jun 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.
This study aimed to detect the possibility of using venous pressure as a predictor for high flow access as a simple, non-invasive screening technique in hemodialysis patients.
Detailed description
The patient's vascular access is often referred to as their "lifeline," and without it, the life-sustaining treatment of hemodialysis would not be possible. To maintain access, patency depends on accurate diagnosis and timely, active interventions.
The Kidney Disease Outcomes Quality Initiative (K/DOQI) recommends native arteriovenous fistula (AVF) as the vascular access of choice for hemodialysis due to its longevity, lower complications, and lower mortality rate compared to catheters.
Currently, K/DOQI guidelines suggest that high intra-access pressure may be regarded as a surrogate for arteriovenous fistula (AVF) outflow stenosis. It can be measured using static venous pressure (sVP) or standardized dynamic venous pressure (dVP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Venous Pressure Monitoring, Other: Color Doppler UltrasoundChronic hemodialysis patients of both sexes with autogenous arteriovenous fistulas. |
Who may qualify
- Ages
- 28 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective cohort study enrolled 59 chronic hemodialysis patients of both sexes with autogenous arteriovenous fistula (AVF).
Key inclusion criteria (3 listed)
- Age from 28 to 81.
- Both sexes.
- Patients with the presence of an autogenous arteriovenous fistula (AVF) and a minimum hemodialysis treatment duration of six months.
Key exclusion criteria (2 listed)
- Physical examination revealed signs of AVF outflow stenosis, including localized edema, collateral circulation, hyperpulsatile fistula characteristics, or a positive hand elevation test.
- If ultrasound confirmed AVF stenosis or thrombosis, or angiography identified central venous stenosis or thrombosis in clinically suspected cases.
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 |
|---|---|---|
| Venous Pressure MonitoringMeasurement of venous pressure will be taken at dialysis machine pump speed set at 200ml/min, fistula needle gauge 16. | Other | Study group |
| Color Doppler UltrasoundArteriovenous fistula (AVF) Access flow (QA) will be obtained using color Doppler ultrasound using the Mindray-M5 ultrasound system. AVF feeding arterial flow will be measured immediately proximal to the fistula. The QA volume will be obtained using the algorithm available on the system, which is based on the mean flow of two measurements. | Other | Study group |
Primary outcome
Static venous pressure
Time frame: 6 months post-procedure
Static venous pressure (SVP) were measured with the blood pump deactivated through direct intra-access measurement via the venous outflow cannulation needle. Blood pressure (BP)-adjusted values were calculated using the patient's mean arterial blood pressure (MAP) recorded contemporaneously with venous pressure measurements.
3 secondary outcomes
Standardized dynamic venous pressure
Time frame: 6 months post-procedure
Arteriovenous fistula flow
Time frame: 6 months post-procedure
Urea reduction ratio
Time frame: 30 minutes following treatment completion
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 26 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Pressure and Predictor, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 2 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 26 Jun 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 Egypt. 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?
Static venous pressure (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.