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

Completed

• Conditions: Venous Pressure; Predictor; High Flow Access; Hemodialysis

• Registration Number: NCT07038993
• Lead Sponsor: Ain Shams University

Brief 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.

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 Timeline

• Study Start: 2017-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Static venous pressure	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 Outcome Measures

Name	Time	Method
Standardized dynamic venous pressure	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.
Arteriovenous fistula flow	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.
Urea reduction ratio	30 minutes following treatment completion	Urea reduction ratio (URR) was subsequently calculated as an indicator of hemodialysis treatment adequacy.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt