跳至主要内容
临床试验/CTRI/2020/02/023319
CTRI/2020/02/023319尚未招募不适用

Biomarker enhanced management of acute kidney injury in Indian patients

BioMerieux India Pvt Ltd11 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年2月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
11
主要终点
Development of acute kidney injury.

研究概览

简要总结

Acute Kidney Injury (AKI) is a complex disorder encountered from 5% in hospitalized patients and 40-60% in ICU setting. it is associated with high mortality and increased resource utilization . Clinical trials have demonstrated the efficacy of these new biomarkers in detecting kidney damage, predicting disease progression and determining potential recovery. Two Randomized clinical trials have shown the efficacy of TIMP2 and IGFBP biomarkers in Cardiac surgery (PREVAKI)2 and high risk surgery patients (BIGPAK)3 to improve outcomes. Unfortunately the adoption of damage biomarkers into routine clinical care worldwide has been limited. In This study we propose to characterize the utility of nephrocheck in the diagnosis,  differentiation and management of AKI in patients with sepsis and major surgery in the ICU across multiple centers in india provide new information on patterns of AKI development, course and management and ascertain the barriers to boimarker applications in this setting.  The data obtained will inform the development of best practices for optimal utilization of the nephrocheck markers to improve outcomes from AKI.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age > 18 admitted to ICUs Diagnosis of sepsis or following major surgery.
  • High risk of developing AKI based on the Malhotra score > 88.

排除标准

  • Unable to give consent and absence of any surrogate to give consent Chronic hemodialysis or peritoneal dialysis within the past 12 months Functioning kidney transplantation Patients not expected to survive more than 48 h Prisoners.

结局指标

主要结局

Development of acute kidney injury.

时间窗: Day 7 after enrollment.

次要结局

  • 1.Requirement of dialysis.(2.length of hospital and ICU stay.)

研究者

发起方
BioMerieux India Pvt Ltd
申办方类型
Pharmaceutical industry-Global

研究点 (11)

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