Carotid ultrasound to predict blood pressure drops during dialysis
The Predictive Value of Carotid Corrected Flow Time and Peak Flow Velocity Variability for Intradialytic Hypotension: A Prospective Multicenter Observational Study
We're testing whether carotid ultrasound measurements can help predict which adults on long-term hemodialysis will have drops in blood pressure during treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 183 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wannan Medical College Academic / other |
| Locations | 1 site (Wuhu, Outside of the US) |
| Trial ID | NCT07033260 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective observational study will enroll adults with end-stage renal disease receiving maintenance hemodialysis to measure carotid corrected flow time (FTc) and peak flow velocity variability (PFVV). Ultrasound assessments will be performed once at about one hour after dialysis initiation while blood pressure is continuously monitored during the session. The primary analysis will determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV for predicting intradialytic hypotension. Patients with major carotid stenosis, significant arrhythmias, hemodynamic instability, or inability to undergo ultrasound are excluded.
Who should consider this trial
Good fit: Adults aged 18–80 with end-stage renal disease who have been on maintenance hemodialysis for at least three months and can undergo carotid ultrasound and give informed consent.
Not a fit: Patients with significant carotid stenosis, unstable cardiovascular status, major arrhythmias, inability to receive ultrasound, or those taking antihypertensive medications during dialysis are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this could allow clinicians to identify patients at high risk for intradialytic hypotension and take preventive steps during dialysis.
How similar studies have performed: Small prior studies and physiologic data support a link between carotid flow measures and volume or hemodynamic status, but large multicenter validations are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhu, Outside of the US
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) — Wuhu, Outside of the US, China (Recruiting)
Study contacts
- Study coordinator: Qiancheng Xu
- Email: qianchengxu@wnmc.edu.cn
- Phone: 86-18297529106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.