Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome (NEEDED)

National Institute of Cardiology Ignacio Chavez

Status: Enrolling

Conditions: Cardiorenal Syndrome Type 1

Treatments: Other: Diuretic de/escalation based on ultrasound findings (VExUS Score); Other: Diuretic de/escalation based on clinical findings (CCS Score)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06065163

22-1339

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Ultrasound Guided Treatment

Experimental group

Description:

Patients allocated to this will be guided (diuretic treatment) by ultrasound (VExUS) findings

Treatment:

Other: Diuretic de/escalation based on ultrasound findings (VExUS Score)

Clinical Guided Treatment

Active Comparator group

Description:

Patients allocated to this will be guided (diuretic treatment) by clinical congestion score (CCS) findings

Treatment:

Other: Diuretic de/escalation based on clinical findings (CCS Score)