Postoperative Kidney Functions in Geriatric Major Gynecologic-Oncologic Surgery

Geriatrics Clinical Trial

Official title:

Evaluation of Postoperative Kidney Functions in Geriatric Patients Undergoing Major Gynecologic-Oncologic Surgery: A Retroceptive - Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05308810
• Other study ID #: E1-22-2381
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Injury
• Geriatrics
• Gynecologic Surgery

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