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临床试验/NCT03597854
NCT03597854Unknown不适用

Renal Outcome of Acute Kidney Disease in Critically Ill Patients: A Prospective Observational Study

Sanjay Gandhi Postgraduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年6月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
To know renal outcome of acute kidney disease (AKD) among ICU survivors at 90 days after exposure to an acute kidney injury initiating event.

研究概览

简要总结

Both, acute kidney injury (AKI) and chronic kidney disease (CKD) considered as a continuum of the disease process. The renal recovery after AKI is currently assessed by measuring serum creatinine, which has its limitations including change in muscle mass, volume distribution in critically ill patients. Also, despite complete return of serum creatinine after AKI, these patients remain at increased risk for developing CKD, which suggest that there may be persistent subclinical damage to the kidney. The new term acute kidney disease (AKD) has been proposed to define the renal disease after AKI. Recently (2017), Acute Disease Quality Initiative (ADQI) 16 workgroup published a consensus document on AKD and renal recovery, which provide definition as well as research recommendation for AKD. The consensus report of the ADQI 16 workgroup (2017) recommended that there is need for studies to describe the epidemiology, clinical course, natural history of patients having AKD; and also determine optimal methods to assess functional recovery and identify novel biomarker(s), functional tests, and imaging approach which can reveal ongoing injury and repair in these patients. This is an observational study to describe epidemiology, clinical course and recovery from AKD at 90 days in critically ill patients.

详细描述

Introduction and Background:

There are available definitions for acute kidney injury (AKI) and chronic kidney disease (CKD), which are being used routinely in research and clinical practice. The AKI is defined as an abrupt decrease in kidney function occurring over 7 days or less, as per KDIGO (kidney disease improving global outcome) guideline. The CKD is defined as persistence of kidney disease for a period of more than 90 days.

Both, AKI and CKD considered as a continuum of the disease process. The renal recovery after AKI is currently assessed by measuring serum creatinine, which has its limitations including change in muscle mass, volume distribution in critically ill patients. Also, despite complete return of serum creatinine after AKI, these patients remain at increased risk for developing CKD, which suggest that there may be persistent subclinical damage to the kidney. The new term acute kidney disease (AKD) has been proposed to define the renal disease after AKI. Recently (2017), Acute Disease Quality Initiative (ADQI) 16 workgroup published a consensus document on AKD and renal recovery, which provide definition as well as research recommendation for AKD.

Rationale of the study supported by cited literature:

The consensus report of the ADQI 16 workgroup (2017) recommended that there is need for studies to describe the epidemiology, clinical course, natural history of patients having AKD; and also determine optimal methods to assess functional recovery and identify novel biomarker(s), functional tests, and imaging approach which can reveal ongoing injury and repair in these patients.

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 ICU patients who are ≥18 years and had AKD

排除标准

  • Age <18 years
  • Not known AKI initiating event day
  • Any known renal disease (like CKD, nephritic or nephrotic syndrome)
  • Pregnancy

结局指标

主要结局

To know renal outcome of acute kidney disease (AKD) among ICU survivors at 90 days after exposure to an acute kidney injury initiating event.

时间窗: 90 days after exposure to an acute kidney injury initiating event.

To study the renal outcome of AKD (among survivors) at 90 days, by measuring serum creatinine.

次要结局

  • Incidence of acute kidney disease (AKD) among ICU patients(15 months)

研究者

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

Mohan Gurjar

Principal Investigator

Sanjay Gandhi Postgraduate Institute of Medical Sciences

研究点 (1)

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