Venous Pressure Monitoring As a Predictor Of High-Flow Access In Prevalent Hemodialysis Patients

NCT ID: NCT07038993

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Pressure Predictor High Flow Access Hemodialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Chronic hemodialysis patients of both sexes with autogenous arteriovenous fistulas.

Venous Pressure Monitoring

Intervention Type OTHER

Measurement of venous pressure will be taken at dialysis machine pump speed set at 200ml/min, fistula needle gauge 16.

Color Doppler Ultrasound

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Venous Pressure Monitoring

Measurement of venous pressure will be taken at dialysis machine pump speed set at 200ml/min, fistula needle gauge 16.

Intervention Type OTHER

Color Doppler Ultrasound

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

28 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ashraf Hassan

Lecturer of Internal Medicine and Nephrology, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMASU MD221/2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lymphatic Occlusion Pressure in Lower Limb
NCT02405559 UNKNOWN EARLY_PHASE1