Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wuhu County Traditional Chinese Medicine Hospital | OTHER |
| Wuhu City Second People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intradialytic Hypotension | The proportion of dialysis sessions experiencing hypotension, defined as a systolic blood pressure decrease ≥20 mmHg or associated symptoms. | Up to one dialysis session (4 hours) |
| Correlation Between IVC Parameters and Blood Pressure Changes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiancheng Xu | Contact | 86-18297529106 | qianchengxu@wnmc.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) | Recruiting | Wuhu | Anhui | 241000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
| Up to one dialysis session (4 hours) |