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临床试验/NCT06341816
NCT06341816Unknown不适用

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

Inonu University0 个研究点目标入组 100 人开始时间: 2024年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
acute kidney injury

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with a life expectancy of more than 24 hours

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: VEXUS score (Other)

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.

干预措施: NGAL (Diagnostic Test)

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.

干预措施: VEXUS score (Other)

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.

干预措施: NGAL (Diagnostic Test)

结局指标

主要结局

acute kidney injury

时间窗: first week

it will evaluate according to KDİGO criteria

mortality

时间窗: in 28 days

in 28 days mortality

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Belin Ozer

Prof. Dr.

Inonu University

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