NCT05308810

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 18, 2022

Last Update Submit

April 1, 2022

Conditions

Keywords

GeriatricsAcute Renal InjuryGynecologic Surgery

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

Major Gynecologic-Oncologic surgery between january 2020 - january 2022

Eligibility Criteria

Age65 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsundergone major abdominal gynecologic oncologic surgery between
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • patients underwent major abdominal gynecologic oncologic surgery between January 2021 and January 2022
  • followed in the PACU

You may not qualify if:

  • Patients with inaccessible data and missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Aysun Postaci

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Namık Özcan

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

March 18, 2022

First Posted

April 4, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations