跳至主要内容
临床试验/NCT02376712
NCT02376712Unknown不适用

Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Diagnostic value of urinary indices in differentiating pre-renal and renal AKI

研究概览

简要总结

The study aims to evaluate the diagnostic value of urinary indices in differentiating pre-renal and renal acute kidney injury among critically ill patients.

详细描述

Critically ill patients with acute kidney injury (AKI) will be included. Urinary indices will be obtained immediately after defining AKI, including specific gravity (SG), urine osmolarity (Uosm), urine sodium (UNa), fractional excretion of sodium (FENa), and fractional excretion of urea (FEurea).

The patterns of renal function and hemodynamic status serve as the clinical definition of pre-renal and renal AKI. Hemodynamic status will be evaluated at inclusion and followed during patients' ICU stay. Those who are hemodynamically stable at inclusion are classified as renal AKI. Those who are hemodynamically unstable at inclusion are followed until hemodynamic stabilization. Those with AKI recovery after hemodynamic stabilization are classified as pre-renal AKI. Those without AKI recovery are defined as renal AKI.

Urinary indices are measured again after hemodynamic stability. One of the investigators objectives is to evaluate the diagnostic value of urinary indices using recovery of renal function after hemodynamic stabilization as the definition of pre-renal AKI.

Transesophageal echocardiography (TEE) has been proved to be a reliable method of measuring left renal blood flow during surgical operation. Decreased renal blood flow measured by TEE may serve as an objective definition of pre-renal AKI. The mesurement will be conducted at inclusion if the patient is sedated, intubated, and without TEE contraindication. If the patient is hemodynamically unstable at inclusion, the measurement will be repeated after hemodynamic stabilization. The investigators study also serves the following aims: (1) feasibility of measuring renal blood flow by TEE among critically ill patients; (2) the correspondence between renal blood flow measured by TEE and clinical definition of pre-renal and renal AKI; (3) the diagnostic value of urinary indices in differentiating pre-renal and renal AKI, which is judged by renal blood flow measured by TEE.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients admitted to Medical ICU of PUMCH with one of the following:
  • Increase in serum creatinine by ≥ 26.5 umol/l within 48 hours;
  • Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;
  • Urine volume < 0.5ml/kg/h for 1 hour.

排除标准

  • Obstructive renal disease
  • Renal replacement therapy (RRT) for chronic kidney disease

结局指标

主要结局

Diagnostic value of urinary indices in differentiating pre-renal and renal AKI

时间窗: At ICU admission and during ICU stay

Urinary indices will be compared between patient groups (pre-renal and renal AKI). Sensitivity analysis will be applied to the cut off values of renal blood flow measured by TEE. Sensitivity and specificity of the indices will be calculated. Receiver operating characteristic curves will be plotted.

次要结局

  • Feasibility of measuring renal blood flow among critically ill patients(At ICU admission and during ICU stay)

研究者

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

Bin Du

Director of Medical ICU

Peking Union Medical College Hospital

研究点 (1)

Loading locations...

相似试验

Diagnostic Value of Urinary Indices in... | 临床试验