Actively Recruiting
Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension
Led by First Affiliated Hospital of Wannan Medical College · Updated on 2025-06-24
183
Participants Needed
1
Research Sites
30 weeks
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
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.
CONDITIONS
Official 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 greater than 70% confirmed by ultrasound or angiography
- Hemodynamically unstable or requiring vasopressor support
- Significant arrhythmias such as atrial fibrillation or ventricular tachycardia
- Dialysis sessions ended for reasons unrelated to hypotension
- Use of antihypertensive medications during dialysis sessions
- Unable to undergo ultrasound due to severe obesity or wounds obstructing access
- Withdrawal of informed consent during the study
AI-Screening
AI-Powered Screening
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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
CONTACT
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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