Treatment According to Venous Excess Ultrasound Score in Patients With Heart Failure

NCT06341816 | Not Yet Recruiting

• 1 other identifier: VEXUS2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heart Failure; Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• acute kidney injury

  it will evaluate according to KDİGO criteria

  first week

• mortality

  in 28 days mortality

  in 28 days

Study Arms (2)

Conventional

ACTIVE COMPARATOR

In the conventional group, heart failure treatment will be managed according to classical physical examination (e.g. peripheral edema, rales) and laboratory methods (pro-BNP). e.g. fluid restriction, diuretic therapy, etc.

Other: VEXUS score; Diagnostic Test: NGAL

VEXUS

ACTIVE COMPARATOR

In the vexus group, heart failure treatment will be given in a way that will reduce the vexus score. e.g. fluid restriction, diuretic therapy, etc.

Other: VEXUS score; Diagnostic Test: NGAL

Interventions

VEXUS score OTHER

The VExUS score is obtained as follows: VEXUS 0: IVC \< 20mm; VEXUS 1: IVC ≥ 20mm with normal patterns or mild abnormalities; VEXUS 2: IVC ≥ 20mm with severe abnormality in at least one pattern and VEXUS 3: IVC ≥ 20mm and severe abnormalities in multiple patterns.

Conventional; VEXUS

NGAL DIAGNOSTIC_TEST

Neutrophil gelatinase-associated lipocalin

Conventional; VEXUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a life expectancy of more than 24 hours
• \>18 age

You may not qualify if:

• Poor abdominal echogenicity
• age \< 18
• postoperative patients,
• intoxications,
• life expectancy is less than 24 hours,
• pregnancy,
• 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

Sponsors & Collaborators

• Inonu University: lead

MeSH Terms

Conditions

Heart Failure; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Ayse B OZER

CONTACT

+904223410660; abelinozer@gmail.com

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: Prof. Dr.

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 2, 2024
• Study Start: April 25, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share