RecruitingNot Applicable

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

China183 participantsStarted 2025-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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. Exclusion Criteria: Patients with significant carotid artery stenosis due to heavy atherosclerotic plaque (defined as more than 70% stenosis confirmed by ultrasound or angiography). Hemodynamically unstable patients or those requiring vasopressor support. Patients with significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia). Dialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request). Use of antihypertensive medications during dialysis sessions. Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access. Patients who withdraw informed consent during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Predictive Value of Carotid Corrected Flow Time (FTc) for Intradialytic Hypotension

Timeframe: 1 hour after dialysis start during a single session.

Predictive Value of Peak Flow Velocity Variability (PFVV) for Intradialytic Hypotension

Timeframe: 1 hour after dialysis start during a single session.

Trial details

NCT IDNCT07033260

SponsorFirst Affiliated Hospital of Wannan Medical College

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-30

Contact for this trial

Qiancheng Xu

86-18297529106 qianchengxu@wnmc.edu.cn

View on ClinicalTrials.gov More Intradialytic Hypotension trials