Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

NCT ID: NCT06065163

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-03-31

Brief Summary

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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

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Conditions

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Cardiorenal Syndrome Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Experimental, randomized, double-blind, and prospective study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ultrasound Guided Treatment

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Clinical Guided Treatment

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Interventions

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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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EchoNous Inc.

INDUSTRY

Sponsor Role collaborator

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role lead

Responsible Party

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Salvador Lopez Gil

Chief of Hemodialysis Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Salvador López Gil, MD

Role: CONTACT

5555732911 ext. 24400

Victor H Gomez Johnson, MD

Role: CONTACT

5591985387

Facility Contacts

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Salvador López Gil, MD

Role: primary

5555732911 ext. 24400

Other Identifiers

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22-1339

Identifier Type: -

Identifier Source: org_study_id

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