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Completed

NCT Number: NCT04130347

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any of the selected procedures.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Incidence of AKI

    Time frame: the first 24- 72 hours postop

    Frequency of AKI as defined by KDIGO

Secondary outcomes

  1. Mortality

    Time frame: 30, 60 and 360 days postoperatively

    30, 60, and 360 day mortality rate

  2. Major Adverse Kidney Events

    Time frame: 30, 60 and 360 days postoperatively

    Renal composite outcome according to Major Adverse Kidney Events (MAKE)

  3. Fluid balance

    Time frame: 24-72h

    Fluid balance during surgery, and the first postoperative days.

  4. Electrolyte disturbances

    Time frame: 24-72h

    Any electrolyte disturbance.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2019
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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