Cardiorenal Syndrome Type 1NCT06786728
Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type -1
A study testing frusemide in people with Cardiorenal Syndrome Type 1, run by Benha University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiorenal Syndrome Type 1
- What is being tested?
- frusemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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),
Show all 9Show fewer
- use of extracorporeal membrane oxygenation (ECMO),
- diagnosis of hepatic cirrhosis or other condition with portal hypertension
- Or postrenal causes of AKI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 ?
- Conditions
- Cardiorenal Syndrome Type 1
- Being tested
- frusemide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frusemideDrug
in this group we use vexus score to asses decongestion in comparison to lung ultrasound in other group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: frusemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (1)
VEXUS score
grade 1 : no congestion grade 2:mild congestion grade 3 moderate congestion grade 4 : severe congestion
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start10 Aug 2024
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorenal Syndrome Type 1Studies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Shahat Mohamedy Behairy, Benha University
- Investigators
- asmaa AS Behairy, master, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786728
- Sponsor's protocol ID
- MD8.1.2024
- Status last verified
- Jan 2025
- First submitted
- 5 Dec 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type-1 : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06786728
- Acronym / sponsor ID
- MD8.1.2024
- Conditions
- Cardiorenal Syndrome Type 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the VEXUS group :in this group we use the vexus score to guide decongestive theapy | Active comparator | Drug: frusemidethe 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 comparator | Drug: frusemideif lung ultrasound score more than 15 we will start diuretic therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients of both genders aged 18-65 years old.
Key exclusion criteria (9 listed)
- • Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frusemidein this group we use vexus score to asses decongestion in comparison to lung ultrasound in other group | Drug | the VEXUS group :in this group we use the vexus score to guide decongestive theapy, the lung US group : we use lung ultrasound score to detect degree of pulmonary congestion |
Primary outcome
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 secondary outcome
VEXUS score
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Cardiorenal Syndrome Type 1
RecruitingPhase 2/3
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Empagliflozin in Cardiorenal Syndrome Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
asmaa AS Behairy, master principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing frusemide in people with Cardiorenal Syndrome Type 1, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assesment of KFR using the KDIGO AKI staging improvement (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.