GeriatricsNCT05308810
Postoperative Kidney Functions in Geriatric Major Gynecologic-Oncologic Surgery
An observational study of Geriatrics and Acute Renal Injury, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years, women only
- Conditions the study is for
- Geriatrics, Acute Renal Injury, Gynecologic Surgery
- What is being tested?
- Major Gynecologic- oncologic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2022to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- Women only
- No healthy volunteers
- Older adult
Study population: patients underwent major abdominal gynecologic oncologic surgery and followed in the PACU between January 2021 and January 2022 at Ankara City hospital
Who may be able to join
- patients underwent major abdominal gynecologic oncologic surgery between January 2021 and January 2022
- followed in the PACU
Who cannot join
- Patients with inaccessible data and missing data
Trial locations and contacts
1 site in 1 country.
Namık Özcan contact
About this study
Official title: 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).
- Conditions
- Geriatrics, Acute Renal Injury, Gynecologic Surgery
- Being tested
- Major Gynecologic- oncologic Surgery
- Keywords
- Geriatrics, Acute Renal Injury, Gynecologic Surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major Gynecologic- oncologic SurgeryProcedure or surgery
Major Gynecologic-Oncologic surgery between january 2020 - january 2022
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysun postaci, Ankara City Hospital Bilkent
- Investigators
- Aysun Postaci, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308810
- Sponsor's protocol ID
- E1-22-2381
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Kidney Functions in Geriatric Patients Undergoing Major Gynecologic-Oncologic Surgery: A Retroceptive - Cohort Study
- ClinicalTrials.gov ID
- NCT05308810
- Acronym / sponsor ID
- E1-22-2381
- Conditions
- Geriatrics, Acute Renal Injury, Gynecologic Surgery
- Keywords
- Geriatrics, Acute Renal Injury, Gynecologic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients underwent major abdominal gynecologic oncologic surgery and followed in the PACU between January 2021 and January 2022 at Ankara City hospital
Key inclusion criteria (2 listed)
- patients underwent major abdominal gynecologic oncologic surgery between January 2021 and January 2022
- followed in the PACU
Key exclusion criteria (1 listed)
- Patients with inaccessible data and missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Major Gynecologic- oncologic SurgeryMajor Gynecologic-Oncologic surgery between january 2020 - january 2022 | Procedure or surgery | – |
Primary outcome
the incidence of the patients with AKI STAGE 1
Time frame: 48 hours after surgery
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
the incidence of the patients with AKI stage 2
Time frame: 48 hours after surgery
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
the incidence of the patients with AKI stage 3
Time frame: 48 hours after surgery
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namık Özcan contact
Aysun Postaci principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatrics and Acute Renal Injury, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysun Postacı (+905323520383, aysunposta@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of the patients with AKI STAGE 1 (time frame: 48 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.