Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type -1
Evaluation of Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type-1 : a Randomized Controlled Trial
1 other identifier
interventional
146
1 country
1
Brief Summary
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 ?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2024
CompletedFirst Submitted
Initial submission to the registry
December 5, 2024
CompletedFirst Posted
Study publicly available on registry
January 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJanuary 22, 2025
January 1, 2025
11 months
December 5, 2024
January 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
assesment of KFR using the KDIGO AKI staging improvement
stage1:serum creatinine increase 1,5 - 2 folds serum creatinine increase 2 - 3 folds serum creatinine increase more than 3 folds
1 week
Secondary Outcomes (1)
VEXUS score
48 hours
Study Arms (2)
the VEXUS group :in this group we use the vexus score to guide decongestive theapy
ACTIVE COMPARATORthe use of diuretic if vexus score more than 1 at time of enrollement
the lung US group : we use lung ultrasound score to detect degree of pulmonary congestion
ACTIVE COMPARATORif lung ultrasound score more than 15 we will start diuretic therapy
Interventions
in this group we use vexus score to asses decongestion in comparison to lung ultrasound in other group
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Asmaa Shahat Mohamedy Behairy
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
asmaa AS Behairy, master
Benha University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Benha University
Study Record Dates
First Submitted
December 5, 2024
First Posted
January 22, 2025
Study Start
August 10, 2024
Primary Completion
July 1, 2025
Study Completion
August 1, 2025
Last Updated
January 22, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share