Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-invasive Monitoring.
- Who it may be relevant to
- Registry conditions: Intradialytic Hypotension, End-Stage Renal Disease Requiring Haemodialysis, Uremia; Chronic, Hemodialysis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Predictive Value of Carotid Corrected Flow Time and Peak Flow Velocity Variability for Intradialytic Hypotension: A Prospective Multicenter Observational Study
Overview
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.
Interventions
- Other Non-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.
Primary outcome measures
- Predictive Value of Carotid Corrected Flow Time (FTc) for Intradialytic Hypotension [Time frame: 1 hour after dialysis start during a single session.]
- Predictive Value of Peak Flow Velocity Variability (PFVV) for Intradialytic Hypotension [Time frame: 1 hour after dialysis start during a single session.]
Secondary outcome measures (2)
- Incidence of Intradialytic Hypotension [Time frame: Up to 1 dialysis session (4 hours)]
- Correlation Between FTc and PFVV and Changes in Blood Pressure [Time frame: 1 hour after dialysis start during a single hemodialysis session (total duration up to 4 hours)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medic — Wuhu
Identifiers
NCT: NCT07033260 · 2025-12