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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05308810
Other study ID # E1-22-2381
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2022
Est. completion date July 2022

Study information

Verified date March 2022
Source Ankara City Hospital Bilkent
Contact Aysun Postaci
Phone +905323520383
Email aysunposta@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The increasing number of patients who develop perioperative acute kidney injury (AKI) is partly related to the aging population and the increasing number of individuals with chronic comorbidities, particularly those with premorbid chronic kidney disease. Anesthesiologists and surgeons will increasingly have to deal with such patients who are elderly and have comorbidities and require major surgery. The aim of this study was to determine the incidence of postoperative acute kidney injury (primary aim) in patients aged 65 and over who underwent elective major gynecological-oncological surgery under general anesthesia in Ankara City Hospital Gynecology-Oncology Operating Room between January 2020-2022 and were followed up in the PACU in the postoperative period. To investigate risk factors and their results in a retrospective manner in line with the KDIGO criteria (secondary purpose).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date July 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender Female
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria: - patients underwent major abdominal gynecologic oncologic surgery between January 2021 and January 2022 - followed in the PACU Exclusion Criteria: - Patients with inaccessible data and missing data

Study Design


Intervention

Procedure:
Major Gynecologic- oncologic Surgery
Major Gynecologic-Oncologic surgery between january 2020 - january 2022

Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of the patients with AKI STAGE 1 AKI STAGE 1 : increase Cr = 0.3 mg/dl or increase Cr to 1.5-1.9 times from baseline; or urine volume < 0.5 ml/kg/h for 6-12 hours
AKI STAGE 2 :
increase to 2-2.9 times from baseline; or urine volume < 0.5 ml/kg/h for = 12 hours
AKI STAGE 3 :
increase Cr to = 3 times from baseline; or increase Cr = 4 mg/dl or initiation of renal replacement therapy or decrease in GFR to <35mL/min/1.73 m2 or urine volume < 0.3 ml/kg/h for = 24 hours or Anuria for = 12 hours
48 hours after surgery
Primary the incidence of the patients with AKI stage 2 AKI STAGE 1 : increase Cr = 0.3 mg/dl or increase Cr to 1.5-1.9 times from baseline; or urine volume < 0.5 ml/kg/h for 6-12 hours
AKI STAGE 2 :
increase to 2-2.9 times from baseline; or urine volume < 0.5 ml/kg/h for = 12 hours
AKI STAGE 3 :
increase Cr to = 3 times from baseline; or increase Cr = 4 mg/dl or initiation of renal replacement therapy or decrease in GFR to <35mL/min/1.73 m2 or urine volume < 0.3 ml/kg/h for = 24 hours or Anuria for = 12 hours
48 hours after surgery
Primary the incidence of the patients with AKI stage 3 AKI STAGE 1 : increase Cr = 0.3 mg/dl or increase Cr to 1.5-1.9 times from baseline; or urine volume < 0.5 ml/kg/h for 6-12 hours
AKI STAGE 2 :
increase to 2-2.9 times from baseline; or urine volume < 0.5 ml/kg/h for = 12 hours
AKI STAGE 3 :
increase Cr to = 3 times from baseline; or increase Cr = 4 mg/dl or initiation of renal replacement therapy or decrease in GFR to <35mL/min/1.73 m2 or urine volume < 0.3 ml/kg/h for = 24 hours or Anuria for = 12 hours
48 hours after surgery
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