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Clinical Trials/CTRI/2021/02/031198
CTRI/2021/02/031198RecruitingNot Applicable

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 site in 1 country139 target enrollmentStarted: February 15, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
139
Locations
1
Primary Endpoint
Acute kidney injury on postoperative day 3

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

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.

Outcomes

Primary Outcomes

Acute kidney injury on postoperative day 3

Time Frame: Acute kidney injury on postoperative day 3

Secondary Outcomes

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

Investigators

Sponsor
All India Institute of Medical Sciences New Delhi
Sponsor Class
Research institution and hospital

Study Sites (1)

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