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NCT Number: NCT07033273

Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension

This multicenter, prospective observational study aims to evaluate the predictive value of the Inferior Vena Cava Collapsibility Index (IVCCI), along with IVC maximum diameter (IVCmax) and IVC minimum diameter (IVCmin), for intradialytic hypotension in patients undergoing maintenance hemodialysis. The study will be 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. Eligible participants are adults aged 18 years or older with diagnosed end-stage renal disease (ESRD), receiving regular hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors likely to influence results will be excluded.

Ultrasound measurements of IVCCI, IVCmax, and IVCmin will be performed once, precisely at 1 hour after dialysis initiation. IVCmax will be measured during inspiration when the IVC is at its largest, and IVCmin during expiration when it is at its smallest. Blood pressure will be monitored continuously during the procedure. The primary objective is to assess the sensitivity, specificity, and optimal cutoff values of IVCCI, IVCmax, and IVCmin for predicting hypotension, aiming to provide a simple and non-invasive tool to facilitate personalized dialysis management and reduce intradialytic hypotension. A sample size of 188 participants is estimated, with data analyzed using ROC curves and multivariate regression methods. The study protocol adheres to ethical standards and regulatory requirements, demonstrating potential to improve patient safety and treatment outcomes.

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Key information

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, Anhui, 241000, China

Location status: Recruiting

Location contact

Shengsheng Tao

CONTACT

[email protected]

86-18315329399

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 years or older.
  • Diagnosed with end-stage renal disease (ESRD).
  • Undergoing regular hemodialysis for at least three months.

Exclusion criteria

  • Pregnant or breastfeeding women.
  • Hemodynamically unstable patients or those requiring vasopressor support.
  • Patients with severe cardiac conditions, including congestive heart failure -classified as NYHA Class III-IV or severe valvular disease.
  • Patients with known allergies to dialysis filters.
  • Dialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request).
  • Patients who withdraw informed consent during the study.
  • Use of antihypertensive medications during dialysis sessions.
  • Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access.

Treatment and study plan

Non-invasive Monitoring

Other

All participants will undergo non-invasive measurement of Inferior Vena Cava Collapsibility Index (IVCCI) using ultrasound and routine blood pressure monitoring before and during hemodialysis sessions. No treatment or experimental intervention will be applied.

Primary outcomes

  1. Predictive Value of IVCCI at 1 Hour for Intradialytic Hypotension

    Time frame: 1 hour after dialysis initiation

    The IVC diameters willbe measured using bedside ultrasonography with a portable ultrasound device. The probe will be placed subcutaneously on the right side of the abdomen, along the mid-axillary line, approximately 2-3 cm below the hepatic vein confluence.End-expiratory diameter (IVCmin): measured during expiration when the IVC is at its smallest. End-inspiratory diameter (IVCmax): measured during inspiration when the IVC is at its largest.

    IVCCI calculated as (IVCmin-IVCmax)/IVCmax × 100% measured 1 hour after dialysis initiation.The sensitivity, specificity, and area under the ROC curve of dIVC in predicting hypotension events during dialysis.

  2. Predictive Value of IVCmax at 1 Hour for Intradialytic Hypotension

    Time frame: 1 hour after dialysis initiation

    The sensitivity, specificity, and ROC of IVCmax measured 1 hour after dialysis initiation in predicting hypotension.

  3. Predictive Value of IVCmin at 1 Hour for Intradialytic Hypotension

    Time frame: 1 hour after dialysis initiation.

    The sensitivity, specificity, and ROC of IVCmin measured 1 hour after dialysis initiation in predicting hypotension.

Secondary outcomes

  1. Incidence of Intradialytic Hypotension

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

    The proportion of dialysis sessions experiencing hypotension, defined as a systolic blood pressure decrease ≥20 mmHg or associated symptoms.

  2. Correlation Between IVC Parameters and Blood Pressure Changes

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

    Analysis of the correlation between IVCmax, IVCmin, and IVCCI measured at 1 hour and changes in systolic, diastolic, and mean arterial pressure from start to 1 hour.

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 the Inferior Vena Cava Collapsibility Index for Intradialytic Hypotension: A Prospective Multicenter Observational Stud

Acronym: IVC-HD

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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