Actively Recruiting

Age: 18Years - 80Years
All Genders
ID07033260

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

Led by First Affiliated Hospital of Wannan Medical College · Updated on 2025-06-24

183

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Wannan Medical College

Lead Sponsor

W

Wuhu City Second People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multicenter, prospective observational study to evaluate whether measurements from carotid ultrasonography can predict hypotension during maintenance hemodialysis. The study focuses on adult patients aged 18 to 80 with end-stage renal disease (ESRD) who have been on long-term hemodialysis for at least three months. The goal is to develop a simple, non-invasive, real-time tool to enhance patient safety and personalize management during dialysis. Participants will undergo non-invasive ultrasound measurements of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) during their routine dialysis sessions. These assessments are performed once, one hour after dialysis starts, alongside continuous blood pressure monitoring during the session. No experimental treatments are given, and the study collects data during a single dialysis session lasting up to four hours. During the study, participants will have ultrasound evaluations and blood pressure checks to determine the relationship between FTc, PFVV, and intradialytic hypotension. Researchers will analyze sensitivity, specificity, and optimal cutoff values of these ultrasound parameters using statistical methods. The total involvement includes one dialysis session for ultrasound and blood pressure monitoring, aiming to improve understanding of hypotension risks during hemodialysis.

CONDITIONS

Brief Title

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Diagnosed with end-stage renal disease (ESRD)
  • Undergoing maintenance hemodialysis for more than three months
  • Willing and able to provide informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Significant carotid artery stenosis due to heavy atherosclerotic plaque (more than 70% stenosis confirmed by ultrasound or angiography)
  • Hemodynamically unstable patients or those requiring vasopressor support
  • Significant arrhythmias such as atrial fibrillation or ventricular tachycardia
  • Dialysis sessions terminated for reasons unrelated to hypotension
  • Use of antihypertensive medications during dialysis sessions
  • Inability to undergo ultrasound assessment due to severe obesity or wounds obstructing access
  • Withdrawal of informed consent during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Single dialysis session lasting up to 4 hours

Participants who undergo routine maintenance hemodialysis are observed with non-invasive carotid ultrasonographic measurements taken before and during dialysis sessions to assess blood flow parameters and their association with intradialytic hypotension.

1 dialysis session visit (in-person)

Trial Site Locations

Total: 1 location

1

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

Wuhu, Outside of the US, China, 241000

Actively Recruiting

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Research Team

Q

Qiancheng Xu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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