Cardiorenal Syndrome Type 1NEEDEDNCT06065163
Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome
A study testing Diuretic de/escalation based on ultrasound findings (VExUS Score) and Diuretic de/escalation based on clinical findings (CCS Score) in people with Cardiorenal Syndrome Type 1, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiorenal Syndrome Type 1
- What is being tested?
- Diuretic de/escalation based on ultrasound findings (VExUS Score) and Diuretic de/escalation based on clinical findings (CCS Score)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 years old or older
- Type 1 cardiorenal syndrome in emergency room at Instituto Nacional de Cardiologia Ignacio Chávez
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, 14080
Salvador López Gil, MD, 5555732911 ext. 24400, salvadorlgil@gmail.com
About this study
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.
- Conditions
- Cardiorenal Syndrome Type 1
- Being tested
- Diuretic de/escalation based on ultrasound findings (VExUS Score), Diuretic de/escalation based on clinical findings (CCS Score)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diuretic de/escalation based on ultrasound findings (VExUS Score)Other
Patients allocated in the experimental arm will have diuretic dosing adjusted based on ultrasound findings (VExUS Score)
Diuretic de/escalation based on clinical findings (CCS Score)Other
Patients allocated in the experimental arm will have diuretic dosing adjusted based on clinical findings (CCS Score)
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Treatment | Experimental | Patients allocated to this will be guided (diuretic treatment) by ultrasound (VExUS) findings Receives: Other: Diuretic de/escalation based on ultrasound findings (VExUS Score) |
| Clinical Guided Treatment | Active comparator | Patients allocated to this will be guided (diuretic treatment) by clinical congestion score (CCS) findings Receives: Other: Diuretic de/escalation based on clinical findings (CCS Score) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decongestion within 7 days
Assess if the ultrasound guided arm achieves faster decongestion
Measured: 7 days
Secondary outcomes (6)
Acutely decompensated heart failure readmission rate
Assess which strategy achieves less readmission rate
Measured: 7 days
Length of hospital stay
Assess which strategy achieves fewer days of hospital stay
Measured: 7 days
Total diuretic dose within 7 days
Assess which strategy has greater diuretic adjustment
Measured: 7 days
Number of participants that initiate kidney replacement therapy
Assess which strategy is associated with kidney replacement therapy
Measured: 30 days
Intrahospital mortality
Assess which strategy achieves less intrahospital mortality
Measured: 30 days
Days alive out of hospital
Assess which strategy achieves more days alive out of hospital
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 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.
- 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
- Factorial
- Model description
- Experimental, randomized, double-blind, and prospective study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- EchoNous Inc.
- Responsible party
- Principal investigator, Salvador Lopez Gil, Instituto Nacional de Cardiologia Ignacio Chavez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065163
- Sponsor's protocol ID
- 22-1339
- Acronym
- NEEDED
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share the clinical study report and results when they´re available
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome
- ClinicalTrials.gov ID
- NCT06065163
- Acronym / sponsor ID
- NEEDED / 22-1339
- Conditions
- Cardiorenal Syndrome Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- EchoNous Inc.
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 3 Oct 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Experimental, randomized, double-blind, and prospective study
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Treatment | Experimental | Other: Diuretic de/escalation based on ultrasound findings (VExUS Score)Patients allocated to this will be guided (diuretic treatment) by ultrasound (VExUS) findings |
| Clinical Guided Treatment | Active comparator | Other: Diuretic de/escalation based on clinical findings (CCS Score)Patients allocated to this will be guided (diuretic treatment) by clinical congestion score (CCS) findings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old or older
- Type 1 cardiorenal syndrome in emergency room at Instituto Nacional de Cardiologia Ignacio Chávez
Key exclusion criteria (8 listed)
- Patients who denied to participate
- Liver disease (cirrohsis)
- Complex congenital heart disease
- Kidney transplant
- Heart transplant
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 |
|---|---|---|
| Diuretic 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) | Other | Ultrasound Guided Treatment |
| Diuretic 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) | Other | Clinical Guided Treatment |
Primary outcome
Decongestion within 7 days
Time frame: 7 days
Assess if the ultrasound guided arm achieves faster decongestion
6 secondary outcomes
Acutely decompensated heart failure readmission rate
Time frame: 7 days
Length of hospital stay
Time frame: 7 days
Total diuretic dose within 7 days
Time frame: 7 days
Number of participants that initiate kidney replacement therapy
Time frame: 30 days
Intrahospital mortality
Time frame: 30 days
Days alive out of hospital
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: Yes. Will share the clinical study report and results when they´re available
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
Enrolling by invitation
Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type -1
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diuretic de/escalation based on ultrasound findings (VExUS Score) and Diuretic de/escalation based on clinical findings (CCS Score) in people with Cardiorenal Syndrome Type 1, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salvador López Gil, MD (5555732911 ext. 24400, salvadorlgil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decongestion within 7 days (time frame: 7 days). 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 5 Oct 2023.