Skip to content

to diagnose the kidney injury in early stages by a biomarker

Evaluation of Plasma and Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) as an early biomarker in predicting Acute Kidney Injury (AKI) in polu trauma patients in surgical Intensive Care Unit.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/004971
Enrollment
400
Registered
2014-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- 1. Male or female arriving in ICU within 24 hours of trauma 2. 18 â?? 65 years of age

Interventions

Intervention1: NGAL ELISA Kit: Upon admission, and at 24 and 48 hours, 2 ml of blood will be collected in EDTA anti-coagulated vacuettes and 2 ml urine will be collected and centrifuged at 800 x g for

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female arriving in ICU within 24 hours of trauma 2. 18 â?? 65 years of age

Exclusion criteria

Exclusion criteria: • Age 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

Design outcomes

Primary

MeasureTime frame
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. Time frame: 5 days after ICU admission Timepoint: 2 years 6 months

Secondary

MeasureTime frame
â?¢ Cut off value of plasma and urine NGAL for various stages of AKI â?¢ ICU stay â?¢ Need for RRT â?¢ Hospital Stay â?¢ Mortality Timepoint: 2 years 6 months

Countries

India

Contacts

Public ContactDr Babita Gupta

AIIMS, New Delhi

drbabitagupta@hotmail.com09868397815

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026