Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension

Recruiting

• Conditions: End-Stage Renal Disease Requiring Haemodialysis; Intradialytic Hypotension

• Registration Number: NCT07033273
• Lead Sponsor: First Affiliated Hospital of Wannan Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-27
• Status Verified: 2025-06
• Study First Submitted: 2025-06-14
• Study First Submitted QC: 2025-06-14
• Last Update Submitted: 2025-06-14
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive Value of IVCCI at 1 Hour for Intradialytic Hypotension	1 hour after dialysis initiation	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.
Predictive Value of IVCmax at 1 Hour for Intradialytic Hypotension	1 hour after dialysis initiation	The sensitivity, specificity, and ROC of IVCmax measured 1 hour after dialysis initiation in predicting hypotension.
Predictive Value of IVCmin at 1 Hour for Intradialytic Hypotension	1 hour after dialysis initiation.	The sensitivity, specificity, and ROC of IVCmin measured 1 hour after dialysis initiation in predicting hypotension.

Secondary Outcome Measures

Name	Time	Method
Incidence of Intradialytic Hypotension	Up to one dialysis session (4 hours)	The proportion of dialysis sessions experiencing hypotension, defined as a systolic blood pressure decrease ≥20 mmHg or associated symptoms.
Correlation Between IVC Parameters and Blood Pressure Changes	Up to one dialysis session (4 hours)	Analysis of the correlation between IVCmax, IVCmin, and IVCCI measured at 1 hour and changes in systolic, diastolic, and mean arterial pressure from start to 1 hour.

Trial Locations

Locations (1)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College); 🇨🇳 Wuhu, Anhui, China