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临床试验/CTRI/2021/04/032778
CTRI/2021/04/032778尚未招募不适用

Evaluation of serum cystatin C for early diagnosis of acute kidney injury in post exploratory laparotomy patients in intensive care unit

Department of Anaesthesia GMCH Chandigarh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Evaluation of serum cystatin C for the early diagnosis of AKI in the postoperative exploratory laparotomy patients who will be admitted in the intensive care unit

研究概览

简要总结

Acute kidney injury is commonly seen in the perioperative period and in the ICU and is associated with a prolonged hospital stay and high morbidity and mortality. Upto 30% of all patients admitted in ICU suffer

from acute kidney injury. About 50-90% mortality rate is seen in ICU patients who at the end require renal transplantation. Hence, the need for early diagnosis of acute kidney injury is required for the early intervention with

prompt implementation of therapeutic measures to save lives. Criteria for early diagnosis of acute kidney injury are available including : RIFLE criteria (Risk, Injury ,Failure, Loss and End stage kidney), AKIN (Acute

kidney injury network), KDIGO( Kidney Disease Improving Global Outcomes). All these are based on serial measurement of serum creatinine and urine output. Serum creatinine is the most common and dominant

marker of Glomerular filtration rate used to make diagnosis and to categorize acute kidney injury in the ICU setting. Serum cystatin C is also an alternative endogenous marker of glomerular filtration rate. It is produced by all

nucleated cells at a constant rate, it’s serum level is only determined by glomerular filtration rate. An ideal marker of acute kidney injury is the one which allows for the early detection with high diagnostic sensitivity and

specificity. The present study will be conducted in the Department of Anaesthesia and Intensive care, Government Medical College and Hospital, Chandigarh. 70  postoperative exploratory laparotomy patients

admitted to ICU, will be enrolled in the study based on inclusion / exclusion criteria. 5 ml blood sample will be taken from  the patients: on the Day 0 i.e. in first 24 hours of admission to ICU(baseline), 48hours, 72

hours and on day 7 of admission to ICU. Acute kidney injury will be defined according to KDIGO criteria. The immunoturbidimetric method on automated random assess chemistry analyser will be used for the

determination of serum cystatin C level. Serum samples for serum cystatin C will be collected and frozen at -80 degree centigrade. From this study we hypothesize that for the early diagnosis of acute kidney injury in

postoperative laparotomy patient who are admitted in ICU, serum cystatin is a better marker than serum creatinine.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •All patients with age 18 years – 60 years admitted to ICU after post-operative exploratory laparotomy surgery.

排除标准

  • •Refusal to consent from patient’s relative Patients recovering from AKI or developing AKI Patients who required renal replacement therapy All patients transferred from another ICU Patients with end stage kidney disease Serum Creatinine beyond range Serum Cystatin C level beyond range Covid 19 and covid 19 suspect patients.

结局指标

主要结局

Evaluation of serum cystatin C for the early diagnosis of AKI in the postoperative exploratory laparotomy patients who will be admitted in the intensive care unit

时间窗: Within 24 hours post admission in ICU(Baseline) | After 48 hours post admission in ICU | After 72 Hours post admission in ICU | Day 7 post admission in ICU

次要结局

  • Correlation of serum cystatin C and serum creatinine in early diagnosis of AKI in the postoperative exploratory laparotomy patients who will be admitted in the intensive care unit.(Within 24 hours post admission in ICU(Baseline))

研究者

发起方
Department of Anaesthesia GMCH Chandigarh
申办方类型
Government medical college

研究点 (1)

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