NCT06786728

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

December 5, 2024

Last Update Submit

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 COMPARATOR

the use of diuretic if vexus score more than 1 at time of enrollement

Drug: frusemide

the lung US group : we use lung ultrasound score to detect degree of pulmonary congestion

ACTIVE COMPARATOR

if lung ultrasound score more than 15 we will start diuretic therapy

Drug: frusemide

Interventions

in this group we use vexus score to asses decongestion in comparison to lung ultrasound in other group

the VEXUS group :in this group we use the vexus score to guide decongestive theapythe lung US group : we use lung ultrasound score to detect degree of pulmonary congestion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Asmaa Shahat Mohamedy Behairy

Cairo, Egypt

Location

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • asmaa AS Behairy, master

    Benha University

    PRINCIPAL INVESTIGATOR

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

Locations