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临床试验/NCT06305403
NCT06305403尚未招募不适用

Comparison of Venous Excess Ultrasound Score (VExUS) With Neutrophil Gelatinase-associated Lipocalin (NGAL) in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury

Inonu University0 个研究点目标入组 100 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
ngal

研究概览

简要总结

In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.

To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO.

According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not.

By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined.

详细描述

In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.

Poor abdominal echogenicity, age < 18 years, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), life expectancy less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure > 15 mm Hg, obstructive renal failure or suspected renal artery Defined as the presence of stenosis, liver and kidney transplanted patients, liver and kidney tumors, patients receiving dialysis treatment, single kidney and other kidney abnormalities, right heart failure, acute mesenteric ischemia (GFR) < 30 ml/min/1.73m2. Those with severe acute or chronic renal failure will be excluded from the study.

After patients are diagnosed with sepsis/septic shock, in accordance with the Surviving Sepsis 2021 guide; Cultures will be sent and antibiotics, fluids, and vasopressor treatment will be started if necessary. Standard monitoring of the patients (heart rate, mean arterial pressure, peripheral oxygen saturation) will be performed.

To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of ACI will be made according to KDIGO.

According to KDIGO, patients will be divided into two groups: those who develop ACI and those who do not.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sepsis septic shock

排除标准

  • Poor abdominal echogenicity,
  • other conditions causing shock (hypovolemic, cardiogenic, neurogenic),
  • life expectancy less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure > 15 mm Hg, obstructive renal failure liver and kidney transplanted patients, liver and kidney tumors, patients receiving dialysis treatment, single kidney and other kidney abnormalities, right heart failure, acute mesenteric ischemia chronic renal failure

结局指标

主要结局

ngal

时间窗: first and fifth days

neutrophil gelatinase-associated lipocalin

VEXUS

时间窗: first and fifth days

venous excess ultrasound score (If VCI diameter is \< 2 cm, there is no congestion. If the VExUS score is 0, and you do not need to proceed further. If VCI\>2, congestion is present. Further examination is necessary to determine the severity of congestion and VExUS scores 1-3.Each of the hepatic, portal and renal veins are subsequently examined and classified as normal, mildly congested, or severely congested. The VExUS system has four grades: Grade 0 represents no congestion in any organ, Grade 1 represents only mild congestive findings, Grade 2 represents severe congestive findings in only one organ, and Grade 3 represents severe congestive findings in at least two out of three organ systems.

次要结局

  • MORTALİTY(28 days)

研究者

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

Ayse Belin Ozer

Head of Intensive Care Unit

Inonu University

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