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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury

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 Type: Observational
• Enrollment (Actual): 499

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Swedish population undergoing cancer surgery with four selected procedures. Age span between 19 and 85 years old.

Description

Inclusion Criteria:

Any of the selected procedures.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Liver resection
Pancreatic resection
HIPEC surgery
Gynecological debulking surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AKI	Frequency of AKI as defined by KDIGO	the first 24- 72 hours postop

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: EPN dnr 2017/218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No