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

NCT07038993 | Completed

• 1 other identifier: FMASU MD221/2017
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Pressure; Predictor; High Flow Access; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months post-procedure

Secondary Outcomes (3)

• Standardized dynamic venous pressure

  6 months post-procedure

• Arteriovenous fistula flow

  6 months post-procedure

• Urea reduction ratio

  30 minutes following treatment completion

Study Arms (1)

Study group

Chronic hemodialysis patients of both sexes with autogenous arteriovenous fistulas.

Other: Venous Pressure Monitoring; Other: Color Doppler Ultrasound

Interventions

Venous Pressure Monitoring OTHER

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

Study group

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.

Study group

Eligibility Criteria

• Age: 28 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A prospective cohort study enrolled 59 chronic hemodialysis patients of both sexes with autogenous arteriovenous fistula (AVF).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine and Nephrology, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: June 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)