Postoperative Kidney Functions in Geriatric Major Gynecologic-Oncologic Surgery

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Renal Injury; Geriatrics; Gynecologic Surgery
• Intervention / Treatment: Procedure: Major Gynecologic- oncologic Surgery

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Aysun Postacı; Phone Number: +905323520383; Email: aysunposta@yahoo.com
• Study Contact Backup: Name: Namık Özcan; Phone Number: +9005324914531

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

patients underwent major abdominal gynecologic oncologic surgery and followed in the PACU between January 2021 and January 2022 at Ankara City hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Aysun Postaci, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Geriatrics; Gynecologic Surgery; Acute Renal Injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: E1-22-2381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No