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

Primary Purpose

Cardiorenal Syndrome Type 1

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Diuretic de/escalation based on ultrasound findings (VExUS Score)
Diuretic de/escalation based on clinical findings (CCS Score)
Sponsored by
Instituto Nacional de Cardiologia Ignacio Chavez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiorenal Syndrome Type 1

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Nacional de Cardiología Ignacio ChávezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound Guided Treatment

Clinical Guided Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2023
Last Updated
October 3, 2023
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
EchoNous Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06065163
Brief Title
Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome
Acronym
NEEDED
Official Title
Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
EchoNous Inc.

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiorenal Syndrome Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Experimental, randomized, double-blind, and prospective study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound Guided Treatment
Arm Type
Experimental
Arm Description
Patients allocated to this will be guided (diuretic treatment) by ultrasound (VExUS) findings
Arm Title
Clinical Guided Treatment
Arm Type
Active Comparator
Arm Description
Patients allocated to this will be guided (diuretic treatment) by clinical congestion score (CCS) findings
Intervention Type
Other
Intervention Name(s)
Diuretic de/escalation based on ultrasound findings (VExUS Score)
Intervention Description
Patients allocated in the experimental arm will have diuretic dosing adjusted based on ultrasound findings (VExUS Score)
Intervention Type
Other
Intervention Name(s)
Diuretic de/escalation based on clinical findings (CCS Score)
Intervention Description
Patients allocated in the experimental arm will have diuretic dosing adjusted based on clinical findings (CCS Score)
Primary Outcome Measure Information:
Title
Decongestion within 7 days
Description
Assess if the ultrasound guided arm achieves faster decongestion
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Acutely decompensated heart failure readmission rate
Description
Assess which strategy achieves less readmission rate
Time Frame
7 days
Title
Length of hospital stay
Description
Assess which strategy achieves fewer days of hospital stay
Time Frame
7 days
Title
Total diuretic dose within 7 days
Description
Assess which strategy has greater diuretic adjustment
Time Frame
7 days
Title
Number of participants that initiate kidney replacement therapy
Description
Assess which strategy is associated with kidney replacement therapy
Time Frame
30 days
Title
Intrahospital mortality
Description
Assess which strategy achieves less intrahospital mortality
Time Frame
30 days
Title
Days alive out of hospital
Description
Assess which strategy achieves more days alive out of hospital
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salvador López Gil, MD
Phone
5555732911
Ext
24400
Email
salvadorlgil@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Victor H Gomez Johnson, MD
Phone
5591985387
Email
vgomezjohnson@gmail.com
Facility Information:
Facility Name
Instituto Nacional de Cardiología Ignacio Chávez
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvador López Gil, MD
Phone
5555732911
Ext
24400
Email
salvadorlgil@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

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