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Completed

NCT Number: NCT07038993

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.

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Key information

Conditions

Venous Pressure Hemodialysis High Flow Access Predictor

Age range

28 year–81 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venous Pressure Monitoring

Other

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

Color Doppler Ultrasound

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Standardized dynamic venous pressure

    Time frame: 6 months post-procedure

    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.

  2. Arteriovenous fistula flow

    Time frame: 6 months post-procedure

    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.

  3. Urea reduction ratio

    Time frame: 30 minutes following treatment completion

    Urea reduction ratio (URR) was subsequently calculated as an indicator of hemodialysis treatment adequacy.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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