The Predictive Value of the Inferior Vena Cava Collapsibility Index for Intradialytic Hypotension: A Prospective Multicenter Observational Stud

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults aged 18 years or older.

• Diagnosed with end-stage renal disease (ESRD).

• Undergoing regular hemodialysis for at least three months.

Locations
Other Locations
China
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
RECRUITING
Wuhu
Contact Information
Primary
Qiancheng Xu
qianchengxu@wnmc.edu.cn
86-18297529106
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 188
Treatments
Maintenance Hemodialysis Patients
Adult patients with end-stage renal disease undergoing maintenance hemodialysis for at least three months, assessed for intradialytic hypotension risk using ultrasound measurements of the Inferior Vena Cava Collapsibility Index (IVCCI).
Sponsors
Leads: First Affiliated Hospital of Wannan Medical College
Collaborators: Wuhu County Traditional Chinese Medicine Hospital, Wuhu City Second People's Hospital

This content was sourced from clinicaltrials.gov