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临床试验/NCT06691607
NCT06691607已完成不适用

The Role of Neutrophil Gelatinase Associated Lipocalin in Early Detection of Acute Kidney Injury and Prediction of Patient Outcome in Critically Ill Patients; a Prospective, Observational, Non-randomized Study

Sohag University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
the capability of serum NGAL levels to identify renal damage early in all patients requiring critical care

研究概览

简要总结

This single-center prospective non-randomized observational research included 120 critically ill persons, at Sohag University hospital's critical care unit. NGAL serum level was assessed at admission to the intensive care unit (NGAL1) and 24 hours after first sample (NGAL2). Cases were categorized into two groups depending on their progression or not to AKI, group A or group B respectively during their intensive care unit stay. Serum NGAL1 and NGAL2 concentrations were compared in relation to development of AKI (group A) or not (group B), need for RRT or not and in relation to mortality.

详细描述

Introduction A sudden and prolonged decline in renal function is defined as acute kidney injury (AKI). (1) Frequency of acute kidney injury is ranged from 30% to 67% of critically ill patient.(2,3). Nowadays the main marker used for diagnosis of AKI is serum creatinine which is functional marker, the change in its serum level may be delayed that delay diagnosis and management and may worsen outcome.(4) Within 1-4 hours following ischemic renal insult, NGAL has been shown to be detectable in the serum and urine, but until nowadays it has no clinical usage.(5, 6).

Patients and methods:

This single-center prospective non-randomized observational research has been performed on 120 cases, admitted to the critical care unit of the Sohag University Hospital between April 2020 and June 2022. A written and informed agreement was obtained from each patient or his first-degree guardian after clearance by the Sohag Faculty of Medicine's Ethics and Research Committee under IRB Registration Number: Soh-Med-23-01-31.

Inclusion criteria: All severely sick ICU patients older than 18 years old were included in the study.

Exclusion criteria: Patients with known chronic renal disease, those receiving hemodialysis, those with transplanted kidney, those with known kidney cancer, and patients who were just released from the ICU.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • All severely sick ICU patients older than 18 years old were included in the study

排除标准

  • Patients with known chronic renal disease, those receiving hemodialysis, those with transplanted kidney, those with known kidney cancer, and patients who were just released from the ICU

结局指标

主要结局

the capability of serum NGAL levels to identify renal damage early in all patients requiring critical care

时间窗: through study completion, an average of 1 year

the capability of serum NGAL levels to identify renal damage early in all patients requiring critical care

次要结局

  • detection of patient outcome either; the need to RRT or patient mortality.(through study completion, an average of 1 year)

研究者

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

Fawzy Abbas Badawy

Assistant professor of Anesthesia

Sohag University

研究点 (1)

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