NCT07033273 Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension
| NCT ID | NCT07033273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Wannan Medical College |
| Condition | End-Stage Renal Disease Requiring Haemodialysis |
| Study Type | OBSERVATIONAL |
| Enrollment | 188 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 188 participants in total. It began in 2025-01-27 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07033273 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying End-Stage Renal Disease Requiring Haemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07033273 currently recruiting?
Yes, NCT07033273 is actively recruiting participants. Contact the research team at qianchengxu@wnmc.edu.cn for enrollment information.
Where is the NCT07033273 trial being conducted?
This trial is being conducted at Wuhu, China.
Who is sponsoring the NCT07033273 clinical trial?
NCT07033273 is sponsored by First Affiliated Hospital of Wannan Medical College. The trial plans to enroll 188 participants.