Acute Kidney Injury in Major Abdominal Surgery: Retrospective Study of 501 Patients

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT04130347
• Lead Sponsor: Uppsala University

Brief Summary

Retrospective study that aims to examine the presence of acute kidney injury (AKI) during major abdominal surgery, non- cardiac surgery. Using clinical and biochemical data in order to establish AKI frequency and risk factors.

Detailed Description

Ethical approval was submitted and approved by the regional ethical committee, Etisk prövningsnämnd Uppsala, # 2017/418.

Patients were selected from the time span of april 2016 to september 2017. The investigators identified 499 patients that had undergone any of the selected procedures. The procedures were, pancreatic resection, HIPEC surgery in colorectal setting, gynecological debulking in metastasized ovarian cancer, and liver resection.

The risk of acute kidney injury (AKI) by the KDIGO definition during the postoperative period will be estimated in the group as a whole, and for each type of surgery separately. In addition the data will be stratified by sex to investigate systematic gender disparities or physiological differences. Length of stay, thirty day and sixty day mortality will secondary endpoints.

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-17
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

Inclusion Criteria

Any of the selected procedures.

Exclusion Criteria

Patient has expressed his or her will to nor participate in any study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of AKI	the first 24- 72 hours postop	Frequency of AKI as defined by KDIGO

Secondary Outcome Measures

Name	Time	Method
Major Adverse Kidney Events	30, 60 and 360 days postoperatively	Renal composite outcome according to Major Adverse Kidney Events (MAKE)
Mortality	30, 60 and 360 days postoperatively	30, 60, and 360 day mortality rate
Electrolyte disturbances	24-72h	Any electrolyte disturbance.
Fluid balance	24-72h	Fluid balance during surgery, and the first postoperative days.