Congestive Heart Failure (CHF), End Stage Chronic Renal Failure, Fluid Overload, Intravascular Congestion
Conditions
Brief summary
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).
Interventions
PROCEDUREHigh-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.
PROCEDUREStandard fluid removal
Receives a standard fluid removal rate of 10 mL/kg/h.
Sponsors
Universidad Autonoma de Nuevo Leon
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Incidence of Intradialytic Hypotension - IDH) | During the interventional hemodialysis session. | 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 | Comparison between Baseline (pre-intervention) and within 24 hours post-intervention. | 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 | The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction and Tolerance Analysis | Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway. | 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 | From the date of randomization until hospital discharge, assessed up to 30 days. | 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 | Prior to the session (Baseline) and within 24 hours post-intervention. | 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 | Prior to the session (Baseline) and within 24 hours post-intervention. | Analyzing the quantitative change in natriuretic peptide (NT-proBNP) levels before and within 24 hours after the session. |
| Subgroup Analysis (Ventricular Function) | From the date of randomization until hospital discharge, assessed up to 30 days. | 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 |
Countries
Mexico
Contacts
CONTACTEdgar Adrián Montemayor, Nephrology Fellow
Outcome results
None listed