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Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

NCT07033260 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 183

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Intradialytic Hypotension
  • End-Stage Renal Disease Requiring Haemodialysis
  • Uremia; Chronic
  • 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.

Sponsors & Collaborators

  • Wuhu City Second People's Hospital

    collaborator OTHER

  • Wuhu County Traditional Chinese Medicine Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wannan Medical College

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-08-30
Completion
2025-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033260 on ClinicalTrials.gov