Heart FailureNCT06389708
Evaluation of VEXUS Score of Patients With Heart Failure in the Intensive Care Unit.
An observational study of Heart Failure and Acute Kidney Injury, run by Inonu University.
Trial summary
Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Kidney Injury
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 Jan 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: heart failure patients in the ICU
Who may be able to join
- • Patients with a life expectancy of more than 24 hours
- >18 age
Who cannot join
- Poor abdominal echogenicity
- age < 18
- postoperative patients,
- intoxications,
- life expectancy is less than 24 hours,
- pregnancy,
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- intraperitoneal pressure > 15 mm Hg,
- obstructive renal failure or suspected,
- presence of renal artery stenosis,
- patients who have had liver and kidney transplants,
- Presence of liver and kidney tumors,
- patients receiving dialysis treatment,
- single kidney and other kidney abnormalities,
- presence of acute mesenteric ischemia
Trial locations and contacts
No sites are listed yet.
About this study
Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3). Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4). Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion.
Read the detailed description
Patients will be randomized according to the sealed envelope method. While classical heart failure fluid management will be applied to patients in the conventional group, diuretic treatment will be given to the vexus group in a way that will reduce the vexus score, and the drugs and doses used in this treatment will be recorded. The development of acute renal failure in patients will be determined according to KDIGO criteria, but confirmation will be made with NGAL. Patients will be divided into two groups: those treated according to the VEXUS score and those treated simultaneously with VEXUS by a second experienced person (INTENSIVE CARE SPECIALIST) but treated conservatively. Patients' vital parameters, complete blood count, biochemistry, coagulation, arterial blood gas, procalcitonin, CRP, troponin, pro-BNP levels on Day 1 and Day 5 will be noted, and distensibility will be detected by USG on Days 1 and 5 among those with an IVC diameter < 2 cm. or collapsibility index, and for those > 2cm, VEXUS score will be calculated. In addition, EF, TAPSE, presence of pleural effusion or B-Line, renal resistive index, renal pulsatility index will be calculated.
- Conditions
- Heart Failure, Acute Kidney Injury
- Medical subject headings
- Heart Failure, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | heart failure patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
VEXUS
Venous excess ultrasound score
Measured: at the first day, at the last day
MORTALİTY
28 day mortality
Measured: in 28 days
AKI
Acute kidney injury rate
Measured: last day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Belin Ozer, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389708
- Sponsor's protocol ID
- VEVUS-HF
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of VEXUS Score of Patients With Heart Failure in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT06389708
- Acronym / sponsor ID
- VEVUS-HF
- Conditions
- Heart Failure, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 29 Apr 2024 (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.
Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3). Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4). Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion.
Detailed description
Patients will be randomized according to the sealed envelope method. While classical heart failure fluid management will be applied to patients in the conventional group, diuretic treatment will be given to the vexus group in a way that will reduce the vexus score, and the drugs and doses used in this treatment will be recorded. The development of acute renal failure in patients will be determined according to KDIGO criteria, but confirmation will be made with NGAL. Patients will be divided into two groups: those treated according to the VEXUS score and those treated simultaneously with VEXUS by a second experienced person (INTENSIVE CARE SPECIALIST) but treated conservatively. Patients' vital parameters, complete blood count, biochemistry, coagulation, arterial blood gas, procalcitonin, CRP, troponin, pro-BNP levels on Day 1 and Day 5 will be noted, and distensibility will be detected by USG on Days 1 and 5 among those with an IVC diameter < 2 cm. or collapsibility index, and for those > 2cm, VEXUS score will be calculated. In addition, EF, TAPSE, presence of pleural effusion or B-Line, renal resistive index, renal pulsatility index will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –heart failure patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- heart failure patients in the ICU
Key inclusion criteria (2 listed)
- • Patients with a life expectancy of more than 24 hours
Key exclusion criteria (14 listed)
- Poor abdominal echogenicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VEXUS
Time frame: at the first day, at the last day
Venous excess ultrasound score
MORTALİTY
Time frame: in 28 days
28 day mortality
AKI
Time frame: last day
Acute kidney injury rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Acute Kidney Injury, run by Inonu University.
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 14 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ayse B OZER (90-5334478924, abelinozer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VEXUS (time frame: at the first day, at the last day). The study lists 3 primary outcomes in all. 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 1 May 2024.