Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

Study Overview
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Brief Summary
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A double-blind, randomized, controlled trial was conducted with the main objective of evaluating if patients with clinical assessment and VExUS reach decongestion faster within a maximum period of 7 days during the hospital stay. Likewise, the study will describe those patients who experience a decrease in serum creatinine (CrS), NT-proBNP at discharge, greater diuretic adjustment, rate of intrahospital readmission, and 30-day mortality.

Official Title
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Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

Conditions
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Cardiorenal Syndrome Type 1

Intervention / Treatment
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* Other: Diuretic de/escalation based on ultrasound findings (VExUS Score)
* Other: Diuretic de/escalation based on clinical findings (CCS Score)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Type 1 cardiorenal syndrome in emergency room at Instituto Nacional de Cardiologia Ignacio Chávez Exclusion Criteria: Patients who denied to participate Liver disease (cirrohsis) Complex congenital heart disease Kidney transplant Heart transplant Severe valvular disease Chronic kidney disease KDIGO G5 and G5d INTERMACS Score 2
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Experimental, randomized, double-blind, and prospective study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Guided Treatment<br>Patients allocated to this will be guided (diuretic treatment) by ultrasound (VExUS) findings | Other: Diuretic de/escalation based on ultrasound findings (VExUS Score)<br>* Patients allocated in the experimental arm will have diuretic dosing adjusted based on ultrasound findings (VExUS Score)<br>|
| Active Comparator: Clinical Guided Treatment<br>Patients allocated to this will be guided (diuretic treatment) by clinical congestion score (CCS) findings | Other: Diuretic de/escalation based on clinical findings (CCS Score)<br>* Patients allocated in the experimental arm will have diuretic dosing adjusted based on clinical findings (CCS Score)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decongestion within 7 days | Assess if the ultrasound guided arm achieves faster decongestion | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acutely decompensated heart failure readmission rate | Assess which strategy achieves less readmission rate | 7 days | 
| Length of hospital stay | Assess which strategy achieves fewer days of hospital stay | 7 days | 
| Total diuretic dose within 7 days | Assess which strategy has greater diuretic adjustment | 7 days | 
| Number of participants that initiate kidney replacement therapy | Assess which strategy is associated with kidney replacement therapy | 30 days | 
| Intrahospital mortality | Assess which strategy achieves less intrahospital mortality | 30 days | 
| Days alive out of hospital | Assess which strategy achieves more days alive out of hospital | 1 month |