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

Regulation of Treatment According to Venous Load Ultrasound Score (VEXUS) in Patients Followed in Intensive Care Due to Heart Failure

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Acute Kidney Injury
• Intervention / Treatment: Other: VEXUS score; Diagnostic test: NGAL

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayse B OZER; Phone Number: +904223410660; Email: abelinozer@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional; 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; 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.; Diagnostic test: NGAL; Neutrophil gelatinase-associated lipocalin
Active Comparator: VEXUS; 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; 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.; Diagnostic test: NGAL; Neutrophil gelatinase-associated lipocalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute kidney injury	it will evaluate according to KDİGO criteria	first week
mortality	in 28 days mortality	in 28 days

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Acute Kidney Injury
• Other Study ID Numbers: VEXUS2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No