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NCT Number: NCT07033260

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

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.

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Key information

Conditions

Intradialytic Hypotension Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis End-Stage Renal Disease Requiring Haemodialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Hemodialysis Immune System Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Organizing Pneumonia Respiratory Tract Diseases Uremia Uremia; Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhu, Outside of the US, 241000, China

Location status: Recruiting

Location contact

Shengsheng Tao

CONTACT

[email protected]

86-18315329399

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1 hour after dialysis start during a single session.

    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.

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

    Time frame: 1 hour after dialysis start during a single session.

    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.

Secondary outcomes

  1. Incidence of Intradialytic Hypotension

    Time frame: Up to 1 dialysis session (4 hours)

    The proportion of dialysis sessions in which patients experience hypotension, defined as a decrease in systolic blood pressure (SBP) of 20 mmHg or more during the session, will be recorded to estimate clinical event frequency.

  2. 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)

    Assessment of the statistical correlation between PVI parameters ( FTc and PFVV) and changes in blood pressure, including systolic blood pressure, diastolic blood pressure, and mean arterial pressure, during the dialysis session.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiancheng Xu

CONTACT

[email protected]

86-18297529106

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Collaborators

  • Wuhu City Second People's Hospital
  • Wuhu County Traditional Chinese Medicine Hospital

Registry information

Official study title

The Predictive Value of Carotid Corrected Flow Time and Peak Flow Velocity Variability for Intradialytic Hypotension: A Prospective Multicenter Observational Study

Acronym: CUPID

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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