Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension

NCT07033273 | Recruiting

• 1 other identifier: 2025-37
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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

Keywords

Intradialytic Hypotension; Hemodialysis; Inferior Vena Cava Collapsibility Index; Blood Pressure Prediction; Vascular Ultrasonography

Outcome Measures

Primary Outcomes (3)

• Predictive Value of IVCCI at 1 Hour for Intradialytic Hypotension

  The IVC diameters willbe measured using bedside ultrasonography with a portable ultrasound device. The probe will be placed subcutaneously on the right side of the abdomen, along the mid-axillary line, approximately 2-3 cm below the hepatic vein confluence.End-expiratory diameter (IVCmin): measured during expiration when the IVC is at its smallest. End-inspiratory diameter (IVCmax): measured during inspiration when the IVC is at its largest. IVCCI calculated as (IVCmin-IVCmax)/IVCmax × 100% measured 1 hour after dialysis initiation.The sensitivity, specificity, and area under the ROC curve of dIVC in predicting hypotension events during dialysis.

  1 hour after dialysis initiation

• Predictive Value of IVCmax at 1 Hour for Intradialytic Hypotension

  The sensitivity, specificity, and ROC of IVCmax measured 1 hour after dialysis initiation in predicting hypotension.

  1 hour after dialysis initiation

• Predictive Value of IVCmin at 1 Hour for Intradialytic Hypotension

  The sensitivity, specificity, and ROC of IVCmin measured 1 hour after dialysis initiation in predicting hypotension.

  1 hour after dialysis initiation.

Secondary Outcomes (2)

• Incidence of Intradialytic Hypotension

  Up to one dialysis session (4 hours)

• Correlation Between IVC Parameters and Blood Pressure Changes

  Up to one dialysis session (4 hours)

Study Arms (1)

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).

Other: Non-invasive Monitoring

Interventions

Non-invasive Monitoring 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.

Maintenance Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 80 years with end-stage renal disease who have been receiving maintenance hemodialysis for more than three months at participating dialysis centers. Participants are required to be able to provide informed consent and cooperate with study procedures.

You may qualify if:

• Adults aged 18 years or older.
• Diagnosed with end-stage renal disease (ESRD).
• Undergoing regular hemodialysis for at least three months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead
• Wuhu County Traditional Chinese Medicine Hospital: collaborator
• Wuhu City Second People's Hospital: collaborator

Study Sites (1)

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

Wuhu, Anhui, 241000, China

RECRUITING

Central Study Contacts

Qiancheng Xu

CONTACT

86-18297529106; qianchengxu@wnmc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: January 27, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)