Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension (CUPID)

First Affiliated Hospital of Wannan Medical College

Status: Enrolling

Conditions: Hemodialysis; Uremia; Chronic; End-Stage Renal Disease Requiring Haemodialysis; Intradialytic Hypotension

Treatments: Other: Non-invasive Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT07033260

2025-12

Details and patient eligibility

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.

Enrollment: 183 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

183 participants in 1 patient group

Maintenance Hemodialysis Patients

Description:

Adult patients aged 18 to 80 years undergoing maintenance hemodialysis for more than three months. All participants will undergo carotid ultrasonography to measure corrected flow time (FTc) and peak flow velocity variability (PFVV) during routine dialysis sessions. The study aims to evaluate the association between these ultrasonographic parameters and the occurrence of intradialytic hypotension.

Treatment:

Other: Non-invasive Monitoring