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RecruitingNCT06065163NEEDEDUpdated Oct 5, 2023

Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

An interventional study of Diuretic de/escalation based on ultrasound findings (VExUS Score) and Diuretic de/escalation based on clinical findings (CCS Score) in Cardiorenal Syndrome Type 1, sponsored by Instituto Nacional de Cardiologia Ignacio Chavez. Recruiting at 1 site in Mexico. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Instituto Nacional de Cardiologia Ignacio Chavez · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year after the study started (first participant enrolled Sep 2022, registered Sep 2023).
  • Started Sep 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
01

Study 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.

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Conditions studied

  • Cardiorenal Syndrome Type 1
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In context

Cardio-Renal Syndrome

76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 46 interventional studies indexed under Cardio-Renal Syndrome.

Browse Cardio-Renal Syndrome studies →

Lead sponsor

Instituto Nacional de Cardiologia Ignacio Chavez is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Care provider)
Enrollment
80 participants (estimated)

Study arms

  • 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)

  • 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)

Interventions

  • OtherDiuretic 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)

  • OtherDiuretic 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)

06

What researchers measure

Primary outcomes

  1. Decongestion within 7 days

    Assess if the ultrasound guided arm achieves faster decongestion

    Time frame: 7 days

Secondary outcomes

  1. Acutely decompensated heart failure readmission rate

    Assess which strategy achieves less readmission rate

    Time frame: 7 days

  2. Length of hospital stay

    Assess which strategy achieves fewer days of hospital stay

    Time frame: 7 days

  3. Total diuretic dose within 7 days

    Assess which strategy has greater diuretic adjustment

    Time frame: 7 days

  4. Number of participants that initiate kidney replacement therapy

    Assess which strategy is associated with kidney replacement therapy

    Time frame: 30 days

  5. Intrahospital mortality

    Assess which strategy achieves less intrahospital mortality

    Time frame: 30 days

  6. Days alive out of hospital

    Assess which strategy achieves more days alive out of hospital

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Instituto Nacional de Cardiología Ignacio Chávez
    Mexico City, 14080, Mexico
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Will share the clinical study report and results when they´re available

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06065163
Lead sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
EchoNous Inc.
Responsible party
Salvador Lopez Gil (Chief of Hemodialysis Unit, Instituto Nacional de Cardiologia Ignacio Chavez) — Principal investigator
First posted
Oct 3, 2023
Start date
Sep 1, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Oct 5, 2023

Study contacts

Salvador López Gil, MD
Contact
salvadorlgil@gmail.com
5555732911 ext. 24400
Victor H Gomez Johnson, MD
Contact
vgomezjohnson@gmail.com
5591985387

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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