Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06389708 |
| Other study ID # |
VEVUS-HF |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2024 |
| Est. completion date |
January 15, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Inonu University |
| Contact |
Ayse B OZER |
| Phone |
90-5334478924 |
| Email |
abelinozer[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
