NCT07033273

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 188 (estimated)
• Sponsor: First Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• End-Stage Renal Disease Requiring Haemodialysis
• Intradialytic Hypotension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: China