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

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ClinicalTrials.gov Identifier: NCT04130347
Recruitment Status : Completed
First Posted : October 17, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Hultström, 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.

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 499 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Acute Kidney Injury in Major Abdominal Surgery: Retrospective Study of 501 Patients
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

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



Primary Outcome Measures :
  1. Incidence of AKI [ Time Frame: the first 24- 72 hours postop ]
    Frequency of AKI as defined by KDIGO


Secondary Outcome Measures :
  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.


Biospecimen Retention:   None Retained
Blood samples collected one year ahead of surgery and one year after surgery.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.
Criteria

Inclusion Criteria:

Any of the selected procedures.

Exclusion Criteria:

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


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Responsible Party: Michael Hultström, Associate professor, Uppsala University
ClinicalTrials.gov Identifier: NCT04130347     History of Changes
Other Study ID Numbers: EPN dnr 2017/218
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases