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:
* Standard Group: Receives a standard fluid removal rate of 10 mL/kg/h. * High-Rate Group: Receives a higher fluid removal rate of over 13 mL/kg/h (with a safety ceiling up to 15 mL/kg/h).
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).
Adults over 18 years old with End-Stage Renal Disease on hemodialysis for at least 3 months.
Admitted to the hospital requiring mechanical fluid removal for acute fluid overload (first in-hospital session).
Clear ultrasound evidence of severe intravascular congestion (such as diffuse B-lines in the lungs or altered VExUS vascular flow patterns).
Hemodynamically stable with a baseline blood pressure of at least 120/80 mmHg.
Baseline low blood pressure (<100/60 mmHg) or active shock (cardiogenic, septic, or distributive).
Acute coronary syndrome (heart attack), severe heart valve disease, or severe fluid around the heart.
Known chronic lung disease.
Pregnancy.
Parallel
High-rate ultrafiltration
Procedure/SurgeryThis 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.
Standard fluid removal
Procedure/SurgeryReceives a standard fluid removal rate of 10 mL/kg/h.
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.
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.
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).
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.
Hospital Stay and Support
Measuring and comparing the difference between both groups in total days of hospital stay and days of supplemental oxygen requirement.
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).
Biomedical and Echocardiographic Variables
Analyzing the quantitative change in natriuretic peptide (NT-proBNP) levels before and within 24 hours after the session.
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Universidad Autonoma de Nuevo Leon
Lead sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborator
