To identify what is the frequency, underlying risks and how is outcome of kidney problems in patients undergoing open abdominal surgery on emergency basis

Recruiting

• Conditions: Sepsis, unspecified organism,

• Registration Number: CTRI/2021/02/031198
• Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-15
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute kidney injury on postoperative day 3	Acute kidney injury on postoperative day 3

Secondary Outcome Measures

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

Trial Locations

Locations (1)

All India Institute of Medical Sciences New Delhi; 🇮🇳 West, DELHI, India

All India Institute of Medical Sciences New Delhi

🇮🇳West, DELHI, India

Dalim Kumar Baidya

Principal investigator

9871568534

dalimkumar.ab8@gmail.com