Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

NCT07033260 | Recruiting

• 1 other identifier: 2025-12
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carotid ultrasonography; Corrected flow time; Peak flow velocity variability; Intradialytic hypotension; Hemodialysis; Ultrasonographic predictors; Vascular ultrasonography; Fluid management; Dialysis safety

Outcome Measures

Primary Outcomes (2)

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

  The carotid corrected flow time (FTc) is the duration of blood flow in the carotid artery, corrected for heart rate, measured using ultrasonography at 1 hour after hemodialysis initiation. This parameter will be evaluated for its ability to predict hypotension episodes during dialysis, with analysis focusing on sensitivity, specificity, and ROC curve to determine diagnostic accuracy.

  1 hour after dialysis start during a single session.

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

  PFVV represents the variation in peak flow velocity in the carotid artery measured by ultrasonography at 1 hour after hemodialysis start. It reflects vascular volume status and elastic properties. Its capacity to predict intradialytic hypotension will be assessed through sensitivity, specificity, and ROC analysis.

  1 hour after dialysis start during a single session.

Secondary Outcomes (2)

• Incidence of Intradialytic Hypotension

  Up to 1 dialysis session (4 hours)

• Correlation Between FTc and PFVV and Changes in Blood Pressure

  1 hour after dialysis start during a single hemodialysis session (total duration up to 4 hours)

Study Arms (1)

Maintenance Hemodialysis Patients

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.

Other: Non-invasive Monitoring

Interventions

Non-invasive Monitoring OTHER

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.

Maintenance Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 80 years with end-stage renal disease who have been receiving maintenance hemodialysis for more than three months at participating dialysis centers. Participants are required to be able to provide informed consent and cooperate with study procedures.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead
• Wuhu City Second People's Hospital: collaborator
• Wuhu County Traditional Chinese Medicine Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Outside of the US, 241000, China

RECRUITING

MeSH Terms

Conditions

Uremia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

Qiancheng Xu

CONTACT

86-18297529106; qianchengxu@wnmc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: February 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)