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临床试验/CTRI/2021/02/031198
CTRI/2021/02/031198招募中不适用

Incidence, risk factors and outcome of acute kidney injury in adult patients undergoing Emergency Laparotomy: A Prospective Observational Study.

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2021年2月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
139
试验地点
1
主要终点
Acute kidney injury on postoperative day 3

研究概览

简要总结

The aims of the study are to identify the incidence, risk factors and long-term adverse renal outcome of patients undergoing emergency laparotomy.

Primary Objective:

To identify the incidence of AKI on postoperative day 3 in adult patients undergoing emergency laparotomy**.**

Secondary objectives

To assess if preoperative arterial blood lactate level and lactate clearance can be used to predict

1.     To identify the incidence of AKI on postoperative day 7 in adult patients undergoing emergency laparotomy.

2.     To identify risk factors of AKI following emergency laparotomy.

3.     To identify in-hospital mortality, length of hospital stay and requirement of renal replacement therapy (RRT) in these patients

4.     To identify long-term adverse renal outcome at 3 months in those developing postoperative AKI

Study design: Prospective observational study

Study Setting: Single centre study in Emergency operation theatre, All India Institute of Medical Sciences, New Delhi

Study population:

Adult patients of either sex aged between 18 and 65 years undergoing emergency laparotomy.

Exclusion criteria

1)    Previous history of chronic kidney disease (CKD) on renal replacement therapy.

2)    History of AKI within 1 week before surgery and being treated with renal replacement therapy.

3)    Refusal to consent.

Sample size:

Anticipated frequency of post-operative AKI following emergency laparotomy is around 7- 20%. With a conservative estimate of 10% incidence and 5% confidence limit, n=139 patients will be required.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of either sex aged between 18-65 years undergoing emergency laparotomy.

排除标准

  • i) Previous history of chronic kidney disease (CKD) on renal replacement therapy.
  • ii) History of AKI within 1 week before surgery and being treated with renal replacement therapy.
  • iii) Refusal to consent.

结局指标

主要结局

Acute kidney injury on postoperative day 3

时间窗: Acute kidney injury on postoperative day 3

次要结局

  • i) Incidence of Acute kidney injury on postoperative day 7(ii) To identify risk factors of AKI following emergency laparotomy.)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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