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| Name | Class |
|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez | OTHER |
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The purpose of this study is to evaluate whether a personalized, high-rate fluid removal strategy guided by ultrasound is as safe and effective as the standard fluid removal rate for patients with advanced kidney disease who are hospitalized due to severe fluid overload (congestion).
When patients with End-Stage Renal Disease (ESRD) on chronic hemodialysis are admitted to the hospital with excess fluid, doctors often need to remove this fluid quickly to relieve symptoms like severe shortness of breath. However, traditional guidelines recommend conservative fluid removal rates-called ultrafiltration (UF) rates-between 10 and 13 mL/kg/h to prevent sudden drops in blood pressure (intradialytic hypotension). Despite these guidelines, doctors in real-world hospital settings frequently use higher rates to provide urgent relief, though this practice lacks strong scientific backing.
This study utilizes advanced bedside ultrasound protocols (such as lung ultrasound and VExUS) to objectively measure the amount of fluid congestion inside the patient's blood vessels. The researchers hypothesize that patients with high ultrasound markers of congestion can safely tolerate higher fluid removal rates because their blood vessels are overfilled, meaning fluid can be pulled out faster without causing blood pressure drops.
Participants will be randomly assigned to one of two groups during their first in-hospital hemodyalisis session:
The study will compare the two groups over the first 24 hours to monitor blood pressure stability (safety) and check for improvements in ultrasound congestion scores, shortness of breath, and the need for supplemental oxygen (effectiveness).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standar Group | Active Comparator | Receives a standard fluid removal rate of 10 mL/kg/h. |
|
| High-Rate Group | Experimental | Receives a higher fluid removal rate of over 13 mL/kg/h (with a safety up to 15 mL/kg/h). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-rate ultrafiltration | Procedure | This intervention consists of fluid removal (ultrafiltration) during the first in-hospital hemodialysis session of a patient with advanced Chronic Kidney Disease, utilizing a high rate greater than 13 mL/kg/h (with a strict safety limit established between >13 and up to 15 mL/kg/h).The differentiating value of this protocol lies in the fact that it challenges traditional medical dogma by combining an aggressive rate with advanced multiparametric ultrasound tools, something that had not been formally structured in previous clinical trials. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Incidence of Intradialytic Hypotension - IDH) | Frequency of episodes defined as a drop in systolic blood pressure (PAS > 20 mmHg) or mean arterial pressure (PAM > 10 mmHg) associated with clinical symptoms requiring medical intervention during the session. | During the interventional hemodialysis session. |
| Ultrasound Efficacy | Improvement in intravascular congestion parameters and cardiac filling pressures, evaluated through a reduction of at least 1 grade in the VExUS score, a 30% decrease in the lung B-line count, and improvement in echocardiographic parameters. | Comparison between Baseline (pre-intervention) and within 24 hours post-intervention. |
| Clinical Respiratory Efficacy | Clinical improvement of the patient measured by the mMRC dyspnea scale and the documented change in the use of supplemental oxygen (fraction of inspired oxygen [FiO_2] or flow in liters per minute). | The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction and Tolerance Analysis | Determining if high baseline VExUS scores and elevated cardiac filling pressures can predict which patients will successfully tolerate the high ultrafiltration rate (>13 mL/kg/h), aiming to establish specific cutoff values using ROC curves. | Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edgar Adrián Montemayor, Nephrology Fellow | Contact | +52 8180911271 | edgar.montemayorga@uanl.edu.mx |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario "Dr. José E. González" | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
Deidentified individual participant data underlying the results reported in the publication
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2026 | Jun 30, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2026 | Jul 10, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2026 | Jun 30, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Standard fluid removal | Procedure | Receives a standard fluid removal rate of 10 mL/kg/h. |
|
| Hospital Stay and Support | Measuring and comparing the difference between both groups in total days of hospital stay and days of supplemental oxygen requirement. | From the date of randomization until hospital discharge, assessed up to 30 days. |
| Blood Pressure Control and Volume | Correlating the total volume of ultrafiltration programmed versus the volume achieved at the end of the session, and comparing the impact on blood pressure control (pre-dialysis vs. post-dialysis at 24 hours). | Prior to the session (Baseline) and within 24 hours post-intervention. |
| Biomedical and Echocardiographic Variables | Analyzing the quantitative change in natriuretic peptide (NT-proBNP) levels before and within 24 hours after the session. | Prior to the session (Baseline) and within 24 hours post-intervention. |
| Subgroup Analysis (Ventricular Function) | Exploring whether Left Ventricular Ejection Fraction (LVEF), natriuretic peptides, or pre-dialysis blood pressure modify or influence the clinical response to the specific ultrafiltration profile used | From the date of randomization until hospital discharge, assessed up to 30 days. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |