Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-invasive Monitoring.
- Who it may be relevant to
- Registry conditions: End-Stage Renal Disease Requiring Haemodialysis, Intradialytic Hypotension. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Predictive Value of the Inferior Vena Cava Collapsibility Index for Intradialytic Hypotension: A Prospective Multicenter Observational Stud
Overview
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.
Interventions
- Other Non-invasive Monitoring
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 outcome measures
- Predictive Value of IVCCI at 1 Hour for Intradialytic Hypotension [Time frame: 1 hour after dialysis initiation]
- Predictive Value of IVCmax at 1 Hour for Intradialytic Hypotension [Time frame: 1 hour after dialysis initiation]
- Predictive Value of IVCmin at 1 Hour for Intradialytic Hypotension [Time frame: 1 hour after dialysis initiation.]
Secondary outcome measures (2)
- Incidence of Intradialytic Hypotension [Time frame: Up to one dialysis session (4 hours)]
- Correlation Between IVC Parameters and Blood Pressure Changes [Time frame: Up to one dialysis session (4 hours)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medic — Wuhu
Identifiers
NCT: NCT07033273 · 2025-37