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