NEEDED: Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez (Other)

Overall Status

Recruiting

CT.gov ID

NCT06065163

Collaborator

EchoNous Inc. (Industry)

Enrollment

Location

Arms

30.9

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiorenal Syndrome Type 1	Other: Diuretic de/escalation based on ultrasound findings (VExUS Score) Other: Diuretic de/escalation based on clinical findings (CCS Score)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Experimental, randomized, double-blind, and prospective studyExperimental, randomized, double-blind, and prospective study

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound Guided Treatment Patients allocated to this will be guided (diuretic treatment) by ultrasound (VExUS) findings	Other: Diuretic 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)
Active Comparator: Clinical Guided Treatment 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) Patients allocated in the experimental arm will have diuretic dosing adjusted based on clinical findings (CCS Score)

Arm

Intervention/Treatment

Experimental: Ultrasound Guided Treatment

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

Other: Diuretic 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)

Active Comparator: Clinical Guided Treatment

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)

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

Outcome Measures

Primary Outcome Measures

Decongestion within 7 days [7 days]
Assess if the ultrasound guided arm achieves faster decongestion

Secondary Outcome Measures

Acutely decompensated heart failure readmission rate [7 days]
Assess which strategy achieves less readmission rate
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
Number of participants that initiate kidney replacement therapy [30 days]
Assess which strategy is associated with kidney replacement therapy
Intrahospital mortality [30 days]
Assess which strategy achieves less intrahospital mortality
Days alive out of hospital [1 month]
Assess which strategy achieves more days alive out of hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Cardiología Ignacio Chávez	Mexico City		Mexico	14080

Sponsors and Collaborators

Instituto Nacional de Cardiologia Ignacio Chavez
EchoNous Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Salvador Lopez Gil, Chief of Hemodialysis Unit, Instituto Nacional de Cardiologia Ignacio Chavez

ClinicalTrials.gov Identifier:

NCT06065163

Other Study ID Numbers:

22-1339

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cardio-Renal Syndrome

Syndrome

Diuretics

Study Results

No Results Posted as of Oct 5, 2023