to diagnose the kidney injury in early stages by a biomarker

Not Applicable

• Conditions: Health Condition 1: null- 1.Male or female arriving in ICU within 24 hours of trauma2.18 â?? 65 years of age

• Registration Number: CTRI/2014/09/004971
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1.Male or female arriving in ICU within 24 hours of trauma

2.18 â?? 65 years of age

Exclusion Criteria

•Age < 18 years or >65 years

•Inability to obtain Informed Consent from patient or representative

• > 24 hrs after insult

•History of previous renal transplantation

• Chronic kidney disease - known medical history with admitting serum Cr >1.4 mg%

•Known or suspected ongoing pre-operative acute renal failure due to any cause, including pre-renal, intrinsic renal or post-renal (obstructive) etiologies (as evidenced by history, clinical presentation, USG, proteinuria (protein/creatinine ratio >0.5) in random urine sample and active urinary sediments , increasing serum creatinine or oliguria pre-operatively)

•Already receiving dialysis

•Any known or suspected renal ischemic insult(such as cardiac arrest) or nephrotoxic insult(other than intravascular contrast procedure) prior to admission

•Cardiac arrest before and during enrolment

•Transfer order within 24 hours

•Probability of survival > 24 hours less likely

•Transfer from other hospital

•Severe head injury with Glasgow Coma Scale of 3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢To establish the diagnostic ability of plasma NGAL and urine NGAL to diagnose AKI (as per RIFLE criteria) as computed by sensitivity and specificity in trauma patients in surgical ICU. <br/ ><br>Time frame: 5 days after ICU admission <br/ ><br>Timepoint: 2 years 6 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
â?¢Cut off value of plasma and urine NGAL for various stages of AKI <br/ ><br>â?¢ICU stay <br/ ><br>â?¢Need for RRT <br/ ><br>â?¢Hospital Stay <br/ ><br>â?¢Mortality <br/ ><br>Timepoint: 2 years 6 months