Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type -1

January 19, 2025 updated by: Asmaa Shahat Mohamedy Behairy, Benha University

Evaluation of Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type-1 : a Randomized Controlled Trial

the goal of this observational study is to evaluate the role of VEXUS score and lung ultrasound to guide decongestive therapy in patients with cardiorenal syndrome type -1. the main question it aims to answer is: Can the VEXUS score and lung ultrasound guide the efffect of decongestive therapy on KFR and decongestion metrics in patients with CRS-1 compared to standard assesment ?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

146

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 Locations

  • Egypt
      • Cairo, Egypt
        • Asmaa Shahat Mohamedy Behairy

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Patients of both genders aged 18-65 years old.

    • Patients with CRS1 criteria (worsening of renal function due to acute heart failure manifested by : ( Dyspnea , orthopnea ,hypoxia , congested neck veins , oliguria and congestion in imaging.)
    • Patients with Modified lung ultrasound score(LUSS) more than 15.

Exclusion Criteria:

  • • Refusal to participate.

    • Patients with renal transplantation.
    • Unknowing baseline creatinine.
    • Patients with a life-threatening indication of RRT (defined as intractable hyperkalemia, acidosis, uremic symptoms) at enrollment,
    • RRT before recruitment,
    • known prehospitalization advanced chronic kidney disease (defined by an estimated GFR <30 mL/min/1.73 m2 or chronic RRT),
    • use of extracorporeal membrane oxygenation (ECMO),
    • diagnosis of hepatic cirrhosis or other condition with portal hypertension
    • Or postrenal causes of AKI

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: the VEXUS group :in this group we use the vexus score to guide decongestive theapy
the use of diuretic if vexus score more than 1 at time of enrollement
Drug: frusemide
in this group we use vexus score to asses decongestion in comparison to lung ultrasound in other group
Active Comparator: the lung US group : we use lung ultrasound score to detect degree of pulmonary congestion
if lung ultrasound score more than 15 we will start diuretic therapy
Drug: frusemide
in this group we use vexus score to asses decongestion in comparison to lung ultrasound in other group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assesment of KFR using the KDIGO AKI staging improvement
Time Frame: 1 week
stage1:serum creatinine increase 1,5 - 2 folds serum creatinine increase 2 - 3 folds serum creatinine increase more than 3 folds
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VEXUS score
Time Frame: 48 hours
grade 1 : no congestion grade 2:mild congestion grade 3 moderate congestion grade 4 : severe congestion
48 hours

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: asmaa AS Behairy, master, Benha University

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)

August 10, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD8.1.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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