An interventional study of High-rate ultrafiltration and Standard fluid removal in End Stage Chronic Renal Failure, Congestive Heart Failure (CHF) and Intravascular Congestion, sponsored by Universidad Autonoma de Nuevo Leon. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Universidad Autonoma de Nuevo Leon · Not applicable, Interventional, and Treatment
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).
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 70 is close to the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Universidad Autonoma de Nuevo Leon is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Receives a standard fluid removal rate of 10 mL/kg/h.
Procedure: Standard fluid removal
Receives a higher fluid removal rate of over 13 mL/kg/h (with a safety up to 15 mL/kg/h).
Procedure: High-rate ultrafiltration
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.
Receives 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.
Time frame: 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.
Time frame: 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).
Time frame: The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention.
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.
Time frame: Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway.
Hospital Stay and Support
Measuring and comparing the difference between both groups in total days of hospital stay and days of supplemental oxygen requirement.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: From the date of randomization until hospital discharge, assessed up to 30 days.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified individual participant data underlying the results reported in the publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 12 months is below that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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Universidad Autonoma de Nuevo Leon