AWARE
Research type
Research Study
Full title
Assessment of Worldwide Acute Kidney Injury (AKI), Renal Angina and Epidemiology
IRAS ID
146714
Contact name
Akash Deep
Contact email
Sponsor organisation
Cincinnati Children’s Hospital Medical Center
Research summary
Not all studies raise significant issues. Some studies may have straightforward ethical or other issues that can be identified and managed routinely. Others may present significant issues requiring further consideration by a REC, R&D office or other review body (as appropriate to the issue). Studies that present a minimal risk to participants may raise complex organisational or legal issues. You should try to consider all the types of issues that the different reviewers may need to consider.
The AWARE study is a multicenter prospective observational study designed to achieve the following three goals:1- Establish the first international pediatric AKI registry to describe in detail the epidemiology and outcome of AKI in different pediatric and cardiac ICUs around the world.
2- Validate the precision of RAI in ruling out AKI in a large, heterogeneous study population.
3- Evaluate the predictive value of using RAI before and after the incorporation of four different urinary AKI biomarkers used in different combinations.To achieve these primary goals, children admitted to PICUs and/or pediatric cardiac ICUs from different US and international centers will be screened for enrollment eligibility (See eligibility criteria section 5). Patients admitted to general PICU and non-surgical patients admitted to cardiac ICUs are considered the target population of AWARE. Patients admitted to neonatal ICUs and post-surgical admissions to cardiac ICUs are not included in AWARE. Both clinical variables and urinary biomarkers would be needed to accomplish the analysis.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0046
Date of REC Opinion
23 Jan 2014
REC opinion
Further Information Favourable Opinion