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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 16, 2019
First Posted Date October 17, 2019
Last Update Posted Date October 18, 2019
Actual Study Start Date April 1, 2016
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2019)
Incidence of AKI [ Time Frame: the first 24- 72 hours postop ]
Frequency of AKI as defined by KDIGO
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 16, 2019)
  • Mortality [ Time Frame: 30, 60 and 360 days postoperatively ]
    30, 60, and 360 day mortality rate
  • Major Adverse Kidney Events [ Time Frame: 30, 60 and 360 days postoperatively ]
    Renal composite outcome according to Major Adverse Kidney Events (MAKE)
  • Fluid balance [ Time Frame: 24-72h ]
    Fluid balance during surgery, and the first postoperative days.
  • Electrolyte disturbances [ Time Frame: 24-72h ]
    Any electrolyte disturbance.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Kidney Injury in Major Abdominal Surgery: Retrospective Study of 501 Patients
Official Title Acute Kidney Injury in Major Abdominal Surgery: Retrospective Study of 501 Patients
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Blood samples collected one year ahead of surgery and one year after surgery.
Sampling Method Non-Probability Sample
Study Population Swedish population undergoing cancer surgery with four selected procedures. Age span between 19 and 85 years old.
Condition Acute Kidney Injury
Intervention Not Provided
Study Groups/Cohorts
  • Pancreatic resection
  • Liver resection
  • HIPEC surgery
  • Gynecological debulking surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 16, 2019)
499
Original Actual Enrollment Same as current
Actual Study Completion Date September 30, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Any of the selected procedures.

Exclusion Criteria:

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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04130347
Other Study ID Numbers EPN dnr 2017/218
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Michael Hultström, Uppsala University
Study Sponsor Uppsala University
Collaborators Not Provided
Investigators Not Provided
PRS Account Uppsala University
Verification Date October 2019