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

October 3, 2023 updated by: Salvador Lopez Gil, Instituto Nacional de Cardiologia Ignacio Chavez
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cardiología Ignacio Chávez
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decongestion within 7 days
Time Frame: 7 days
Assess if the ultrasound guided arm achieves faster decongestion
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Collaborators

EchoNous Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-1339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will share the clinical study report and results when they´re available

IPD Sharing Time Frame

2 months before finishing the study

IPD Sharing Access Criteria

Via email to principal investigator

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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