The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, 241000, China
Location status: Recruiting
NCT Number: NCT07033273
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Wuhu, Anhui, 241000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 1 hour after dialysis initiation
The sensitivity, specificity, and ROC of IVCmax measured 1 hour after dialysis initiation in predicting hypotension.
Time frame: 1 hour after dialysis initiation.
The sensitivity, specificity, and ROC of IVCmin measured 1 hour after dialysis initiation in predicting hypotension.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Wannan Medical College
Other
The Predictive Value of the Inferior Vena Cava Collapsibility Index for Intradialytic Hypotension: A Prospective Multicenter Observational Stud
Acronym: IVC-HD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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