NCT07033273Recruiting
Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension
The Predictive Value of the Inferior Vena Cava Collapsibility Index for Intradialytic Hypotension: A Prospective Multicenter Observational Stud
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 188 (estimated)
- First submitted
- 14 Jun 2025
- Start date
- 27 Jan 2025
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Diseases
- Chronic kidney disease
- NCT number
- NCT07033273
What you commit to
- Study type: Observational
- Planned participants: 188
- From 27 Jan 2025 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antihypertensive medications during dialysis sessions.
Other illness
- 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.
Other
- Pregnant or breastfeeding women.
- Hemodynamically unstable patients or those requiring vasopressor support.
- Dialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request).
- Patients who withdraw informed consent during the study.
- Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access.
Who the study is looking for
- Adults aged 18 years or older.
- Diagnosed with end-stage renal disease (ESRD).
- Undergoing regular hemodialysis for at least three months.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) Coordinator of this site? Confirm its status | Wuhu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.