跳至主要内容
临床试验/NCT06386796
NCT06386796招募中不适用

Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients Admitted to Surgical Intensive Care Unit.

Aswan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Diagnosis of acute kidney injury.

研究概览

简要总结

To study the ability of RRI, measured by bedside Doppler ultrasound, in detecting acute kidney injury in high-risk patients admitted to surgical intensive care unit, Aswan university hospital, compared with renal biomarkers and conventional assessment using urine output and serum creatinine levels.

详细描述

Acute kidney injury (AKI) is a common clinical problem encountered in critically ill patients, frequently in the setting of multiple organ failure, and is an independent risk factor for increase hospital stay and mortality risk.

Early-stage acute kidney injury was first assessed based on the risk, injury, failure, loss and end-stage (RIFLE) criteria in 2004, and then by the Acute Kidney Injury Network (AKIN) criteria in 2007. The Kidney Disease: Improving Global Outcomes (KDIGO) classification, based on both the AKIN and RIFLE criteria, was introduced in 2012, offering an assessment based on baseline creatinine and urine output.

The best strategy in clinical practice is to identify AKI as early as possible, reverse its cause, and even improve the sequelae. In the past decades, several serum creatinine (SCr)-based classification systems have been proposed to define AKI.

The limitations of SCr is that the determinants of SCr (rate of production, apparent volume of distribution, and rate of elimination) are variable. Therefore, there is an unmet need for other objective measures to help detect AKI in a timely manner. The role of several biomarkers in the early prediction or risk assessment of AKI has been proposed, including kidney tubular damage markers (e.g., neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM- 1), liver-type fatty acid-binding protein (L-FABP) and cystatin C).

Cystatin C is a protein from the family of cysteine proteinase inhibitors and is of interest as an early marker of decreased renal function. It is a protein that is synthesized at a constant rate by all cells containing nuclei, secreted into biological fluids: plasma, pleural, ascitic, cerebrospinal fluid, freely filtered through the glomerular membrane (due to its low molecular weight), fully metabolized in the kidneys, not secreted by the proximal renal tubules.

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

  • Patients with severe pre-eclampsia and eclampsia.
  • Polytraumatized patients.
  • Patients admitted to ICU with sepsis.
  • Both genders.
  • Patients above 18 years.

排除标准

  • patients known to have CKD.
  • patients with congenital renal anomalies.
  • patients with renal transplantation.

结局指标

主要结局

Diagnosis of acute kidney injury.

时间窗: Day 0,1,2,3,7

Renal artery resistive index will be measured daily.Cystatin C will be measured on admission, after 24 hours and 72 hours.

Early detection of acute kidney injury.

时间窗: Day 0,1,2,3,7

Renal artery resistive index will be measured daily.Cystatin C will be measured on admission, after 24 hours and 72 hours.

次要结局

  • To predict clinical outcome (clinical improvement)(Day 0,1,2,3,7,30)
  • To predict clinical outcome (death)(Day 0,1,2,3,7,30)
  • To grade the severity of AKI.(day 0,1,2,3,7)
  • To predict clinical outcome (necessity for renal replacement therapy)(Day 0,1,2,3,7,30)

研究者

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

Soudy Salah Hammad

Lecturer of anesthesia and surgical intensive care

Aswan University

研究点 (1)

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