Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

Not Applicable

Recruiting

• Conditions: Cardiorenal Syndrome Type 1
• Interventions: Other: Diuretic de/escalation based on clinical findings (CCS Score); Other: Diuretic de/escalation based on ultrasound findings (VExUS Score)

• Registration Number: NCT06065163
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Study First Posted: 2023-10-03
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Clinical Guided Treatment	Diuretic de/escalation based on clinical findings (CCS Score)	Patients allocated to this will be guided (diuretic treatment) by clinical congestion score (CCS) findings
Ultrasound Guided Treatment	Diuretic de/escalation based on ultrasound findings (VExUS Score)	Patients allocated to this will be guided (diuretic treatment) by ultrasound (VExUS) findings

Primary Outcome Measures

Name	Time	Method
Decongestion within 7 days	7 days	Assess if the ultrasound guided arm achieves faster decongestion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Nacional de Cardiología Ignacio Chávez; 🇲🇽 Mexico City, Mexico