Actively Recruiting
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
Eligibility Criteria
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
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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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