Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension

NCT ID: NCT07033273

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2025-07-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Non-invasive Monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhu County Traditional Chinese Medicine Hospital

OTHER

Sponsor Role: collaborator

Wuhu City Second People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Qiancheng Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiancheng Xu

Role: CONTACT

qianchengxu@wnmc.edu.cn

86-18297529106

Facility Contacts

Shengsheng Tao

Role: primary

taoshengsheng@yjsyy.com

86-18315329399

Other Identifiers

2025-37

Identifier Type: -

Identifier Source: org_study_id