Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

NCT06065163 | Unknown

• 1 other identifier: 22-1339
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 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.

Conditions

Cardiorenal Syndrome Type 1

Outcome Measures

Primary Outcomes (1)

• Decongestion within 7 days

  Assess if the ultrasound guided arm achieves faster decongestion

  7 days

Secondary Outcomes (6)

• Acutely decompensated heart failure readmission rate

  7 days

• Length of hospital stay

  7 days

• Total diuretic dose within 7 days

  7 days

• Number of participants that initiate kidney replacement therapy

  30 days

• Intrahospital mortality

  30 days

Study Arms (2)

Ultrasound Guided Treatment

EXPERIMENTAL

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

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

Clinical Guided Treatment

ACTIVE COMPARATOR

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)

Interventions

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

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

Ultrasound Guided Treatment

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

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

Clinical Guided Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Type 1 cardiorenal syndrome in emergency room at Instituto Nacional de Cardiologia Ignacio Chávez

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead
• EchoNous Inc.: collaborator

Study Sites (1)

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, 14080, Mexico

RECRUITING

Central Study Contacts

Salvador López Gil, MD

CONTACT

5555732911; salvadorlgil@gmail.com

Victor H Gomez Johnson, MD

CONTACT

5591985387; vgomezjohnson@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Hemodialysis Unit

Model Details: Experimental, randomized, double-blind, and prospective study

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 3, 2023
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 months before finishing the study
• Access Criteria: Via email to principal investigator

Locations

ME (1)