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Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06065163
Acronym
NEEDED
Enrollment
80
Registered
2023-10-03
Start date
2022-09-01
Completion date
2025-03-31
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiorenal Syndrome Type 1

Brief summary

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.

Interventions

OTHERDiuretic de/escalation based on ultrasound findings (VExUS Score)

Patients allocated in the experimental arm will have diuretic dosing adjusted based on ultrasound findings (VExUS Score)

OTHERDiuretic de/escalation based on clinical findings (CCS Score)

Patients allocated in the experimental arm will have diuretic dosing adjusted based on clinical findings (CCS Score)

Sponsors

EchoNous Inc.
CollaboratorINDUSTRY
Instituto Nacional de Cardiologia Ignacio Chavez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Experimental, randomized, double-blind, and prospective study

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decongestion within 7 days7 daysAssess if the ultrasound guided arm achieves faster decongestion

Secondary

MeasureTime frameDescription
Number of participants that initiate kidney replacement therapy30 daysAssess which strategy is associated with kidney replacement therapy
Intrahospital mortality30 daysAssess which strategy achieves less intrahospital mortality
Total diuretic dose within 7 days7 daysAssess which strategy has greater diuretic adjustment
Acutely decompensated heart failure readmission rate7 daysAssess which strategy achieves less readmission rate
Length of hospital stay7 daysAssess which strategy achieves fewer days of hospital stay
Days alive out of hospital1 monthAssess which strategy achieves more days alive out of hospital

Countries

Mexico

Contacts

Primary ContactSalvador López Gil, MD
salvadorlgil@gmail.com5555732911
Backup ContactVictor H Gomez Johnson, MD
vgomezjohnson@gmail.com5591985387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026