RecruitingNCT07033260

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

The Predictive Value of Carotid Corrected Flow Time and Peak Flow Velocity Variability for Intradialytic Hypotension: A Prospective Multicenter Observational Study


Sponsor

First Affiliated Hospital of Wannan Medical College

Enrollment

183 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. Conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital, the study will include adult patients (≥18 years) with end-stage renal disease (ESRD) on long-term hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors affecting results will be excluded. Ultrasound assessments of FTc and PFVV will be performed once, at 1 hour after dialysis initiation. Blood pressure will be monitored during the procedure. The primary outcome is to determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV in predicting intradialytic hypotension. The estimated sample size is 183 participants, with analysis performed using ROC curves and multivariate regression. The protocol complies with ethical standards and aims to develop a simple, non-invasive, real-time tool to improve patient safety and individualized management during hemodialysis.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether an ultrasound of the neck arteries (carotid ultrasound) can predict blood pressure drops during dialysis — a common and dangerous problem called intradialytic hypotension — in people with kidney failure. **You may be eligible if...** - You are between 18 and 80 years old - You have end-stage kidney disease (your kidneys have stopped working) - You have been on regular dialysis for more than 3 months - You are willing and able to consent and follow study procedures **You may NOT be eligible if...** - You have severe narrowing of the neck arteries (more than 70% blockage) - You are currently unstable or need medication to keep your blood pressure up - You have other conditions that make you too unwell to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-invasive Monitoring

All participants will undergo non-invasive ultrasonographic measurement of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) before and during hemodialysis sessions. No treatment or experimental intervention will be applied.


Locations(1)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Outside of the US, China

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NCT07033260


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