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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- •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.
研究概览
简要总结
Neutrophil gelatinase-associated lipocalin (NGAL) is emerging as a novel biomarker of AKI from several etiologies. NGAL increases in both serum and urine 48 hours before the rise of creatinine and shows a strong correlation with change in creatinine concentration. An early diagnostic of AKI allows the early institutions of therapeutic measures fir the protection of renal function and improves the prognosis. This possibility is particularly important in the intensive care unit for the treatment of critically ill patients with potential nephrotoxic therapies. Use of NGAL as an early marker of AKI in Polytrauma patients in the surgical intensive care will be studied. This would enable early diagnostic and early protective strategy in patients identified with high risk for developing AKI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female arriving in ICU within 24 hours of trauma 2.18 – 65 years of age.
排除标准
- •â€¢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.
结局指标
主要结局
•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.
时间窗: 2 years 6 months
Time frame: 5 days after ICU admission
时间窗: 2 years 6 months
次要结局
- •Cut off value of plasma and urine NGAL for various stages of AKI(•ICU stay)