Fluid OverloadNCT06101498
Peroperative Fluid Management in Major Gynecological Cancer Surgeries
A study testing Akut kidnet injury(AKI) in people with Fluid Overload and Fluid Loss, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of perioperative fluid management on postoperative kidney damage in gynecological cancer surgeries. The main question[s] it aims to answer are: Does fluid management applied with different hemodynamic monitoring methods affect the risk of postoperative AKI? In our… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fluid Overload, Fluid Loss, Perioperative/Postoperative Complications
- What is being tested?
- Akut kidnet injury(AKI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Sep 2023
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years
- ASA II-III
- Those with normal renal function
Who cannot join
- Patients in renal insufficiency
- Patients with perioperative renal, ureter \& bladder invasion
- Patients in whom perioperative urine monitoring cannot be performed
- Patients undergoing HIPEC
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, Basaksehir, 3268
About this study
Official title: The Effect of Peroperative Fluid Management Strategy on Postoperative Renal Functions in Major Gyneco-oncological Surgeries
The aim of this study is to evaluate the effect of perioperative fluid management on postoperative kidney damage in gynecological cancer surgeries.
The main question[s] it aims to answer are:
Does fluid management applied with different hemodynamic monitoring methods affect the risk of postoperative AKI? In our clinic, three different fluid management strategies are applied depending on the anesthetist experience. Acute kidney injury will be evaluated according to the postoperative AKIN classification of conventional fluid therapy and targeted fluid therapy with noninvasive or minimally invasive monitoring.
Read the detailed description
Our study was designed as a retrospective study. The files of patients over the age of 18 who underwent open abdominal surgery due to ASAII and III gynecological malignancy will be examined retrospectively. Patients who cannot be monitored peroperatively and who undergo HIPEC will be excluded from the study. Patients will be divided into 3 groups according to the fluid management strategy and the hemodynamic monitoring used: Group 1: patients receiving conventional fluid therapy; Group 2: patients receiving targeted fluid therapy with noninvasive monitoring; Group 3: patients receiving targeted fluid therapy with minimally invasive monitoring.
- Conditions
- Fluid Overload, Fluid Loss, Perioperative/Postoperative Complications, Acute Kidney Injury
- Being tested
- Akut kidnet injury(AKI)
- Keywords
- akut kidney injury, goal directed fluid therapy, peroperative fluid management, conventional fluid therapy
- Medical subject headings
- Edema, Postoperative Complications, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akut kidnet injury(AKI)Diagnostic test
Also called AKI developing in the patient group receiving conventional treatment, AKI developing in the patient group receiving non invaziv goal directed therapy, AKI developing in the patient group receiving minimal invaziv goal directed therapy
postoperative 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Conventional fluid therapy | Experimental | Patients who received conventional fluid therapy Receives: Diagnostic Test: Akut kidnet injury(AKI) |
| Non invaziv goal directed therapy | Experimental | Patients who received non invaziv goal directed therapy Receives: Diagnostic Test: Akut kidnet injury(AKI) |
| Minimal invaziv goal directed therapy | Experimental | Patients who received minimal invaziv goal directed therapy Receives: Diagnostic Test: Akut kidnet injury(AKI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of acute kidney injury
Our primary aim was to evaluate the postoperative day(POD1 ) creatinine values(mg/dl)
Measured: Change from preoperative to postoperative day 1(POD1)creatinine values(mg/dl)
Secondary outcomes (1)
Peroperative fluid amounts
The seconder aim to investigate the amount of fluid used peroperatively
Measured: during the operation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Duygu Akyol, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101498
- Sponsor's protocol ID
- 2023.478
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildiz GO, Hergunsel GO, Sertcakacilar G, Akyol D, Karakas S, Cukurova Z. Perioperative goal-directed fluid management using noninvasive hemodynamic monitoring in gynecologic oncology. Braz J Anesthesiol. 2022 May-Jun;72(3):322-330. doi: 10.1016/j.bjane.2021.12.012. Epub 2022 Feb 1.
PubMed 35121063Yu J, Che L, Zhu A, Xu L, Huang Y. Goal-Directed Intraoperative Fluid Therapy Benefits Patients Undergoing Major Gynecologic Oncology Surgery: A Controlled Before-and-After Study. Front Oncol. 2022 Apr 6;12:833273. doi: 10.3389/fonc.2022.833273. eCollection 2022.
PubMed 35463383Russo A, Aceto P, Grieco DL, Anzellotti GM, Perilli V, Costantini B, Romano B, Scambia G, Sollazzi L, Antonelli M. Goal-directed hemodynamic management in patients undergoing primary debulking gynaecological surgery: A matched-controlled precision medicine study. Gynecol Oncol. 2018 Nov;151(2):299-305. doi: 10.1016/j.ygyno.2018.08.034. Epub 2018 Sep 7.
PubMed 30201234Hasselgren E, Hertzberg D, Camderman T, Bjorne H, Salehi S. Perioperative fluid balance and major postoperative complications in surgery for advanced epithelial ovarian cancer. Gynecol Oncol. 2021 May;161(2):402-407. doi: 10.1016/j.ygyno.2021.02.034. Epub 2021 Mar 12.
PubMed 33715894McKenny M, Conroy P, Wong A, Farren M, Gleeson N, Walsh C, O'Malley C, Dowd N. A randomised prospective trial of intra-operative oesophageal Doppler-guided fluid administration in major gynaecological surgery. Anaesthesia. 2013 Dec;68(12):1224-31. doi: 10.1111/anae.12355. Epub 2013 Sep 30.
PubMed 24116747
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peroperative Fluid Management Strategy on Postoperative Renal Functions in Major Gyneco-oncological Surgeries
- ClinicalTrials.gov ID
- NCT06101498
- Acronym / sponsor ID
- 2023.478
- Conditions
- Fluid Overload, Fluid Loss, Perioperative/Postoperative Complications, Acute Kidney Injury
- Keywords
- akut kidney injury, goal directed fluid therapy, peroperative fluid management, conventional fluid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 26 Oct 2023 (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 aim of this study is to evaluate the effect of perioperative fluid management on postoperative kidney damage in gynecological cancer surgeries.
The main question[s] it aims to answer are:
Does fluid management applied with different hemodynamic monitoring methods affect the risk of postoperative AKI? In our clinic, three different fluid management strategies are applied depending on the anesthetist experience. Acute kidney injury will be evaluated according to the postoperative AKIN classification of conventional fluid therapy and targeted fluid therapy with noninvasive or minimally invasive monitoring.
Detailed description
Our study was designed as a retrospective study. The files of patients over the age of 18 who underwent open abdominal surgery due to ASAII and III gynecological malignancy will be examined retrospectively. Patients who cannot be monitored peroperatively and who undergo HIPEC will be excluded from the study. Patients will be divided into 3 groups according to the fluid management strategy and the hemodynamic monitoring used: Group 1: patients receiving conventional fluid therapy; Group 2: patients receiving targeted fluid therapy with noninvasive monitoring; Group 3: patients receiving targeted fluid therapy with minimally invasive monitoring.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional fluid therapy | Experimental | Diagnostic Test: Akut kidnet injury(AKI)Patients who received conventional fluid therapy |
| Non invaziv goal directed therapy | Experimental | Diagnostic Test: Akut kidnet injury(AKI)Patients who received non invaziv goal directed therapy |
| Minimal invaziv goal directed therapy | Experimental | Diagnostic Test: Akut kidnet injury(AKI)Patients who received minimal invaziv goal directed therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years
- ASA II-III
- Those with normal renal function
Key exclusion criteria (5 listed)
- Patients in renal insufficiency
- Patients with perioperative renal, ureter \& bladder invasion
- Patients in whom perioperative urine monitoring cannot be performed
- Patients undergoing HIPEC
- Patients with 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 |
|---|---|---|
| Akut kidnet injury(AKI)Also: AKI developing in the patient group receiving conventional treatment, AKI developing in the patient group receiving non invaziv goal directed therapy, AKI developing in the patient group receiving minimal invaziv goal directed therapypostoperative 24 hours | Diagnostic test | Conventional fluid therapy, Minimal invaziv goal directed therapy, Non invaziv goal directed therapy |
Primary outcome
Evaluation of acute kidney injury
Time frame: Change from preoperative to postoperative day 1(POD1)creatinine values(mg/dl)
Our primary aim was to evaluate the postoperative day(POD1 ) creatinine values(mg/dl)
1 secondary outcome
Peroperative fluid amounts
Time frame: during the operation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Results publication: PubMed 35121063Yildiz GO, Hergunsel GO, Sertcakacilar G, Akyol D, Karakas S, Cukurova Z. Perioperative goal-directed fluid management using noninvasive hemodynamic monitoring in gynecologic oncology. Braz J Anesthesiol. 2022 May-Jun;72(3):322-330. doi: 10.1016/j.bjane.2021.12.012. Epub 2022 Feb 1.
- Results publication: PubMed 35463383Yu J, Che L, Zhu A, Xu L, Huang Y. Goal-Directed Intraoperative Fluid Therapy Benefits Patients Undergoing Major Gynecologic Oncology Surgery: A Controlled Before-and-After Study. Front Oncol. 2022 Apr 6;12:833273. doi: 10.3389/fonc.2022.833273. eCollection 2022.
- Results publication: PubMed 30201234Russo A, Aceto P, Grieco DL, Anzellotti GM, Perilli V, Costantini B, Romano B, Scambia G, Sollazzi L, Antonelli M. Goal-directed hemodynamic management in patients undergoing primary debulking gynaecological surgery: A matched-controlled precision medicine study. Gynecol Oncol. 2018 Nov;151(2):299-305. doi: 10.1016/j.ygyno.2018.08.034. Epub 2018 Sep 7.
- Results publication: PubMed 33715894Hasselgren E, Hertzberg D, Camderman T, Bjorne H, Salehi S. Perioperative fluid balance and major postoperative complications in surgery for advanced epithelial ovarian cancer. Gynecol Oncol. 2021 May;161(2):402-407. doi: 10.1016/j.ygyno.2021.02.034. Epub 2021 Mar 12.
- Results publication: PubMed 24116747McKenny M, Conroy P, Wong A, Farren M, Gleeson N, Walsh C, O'Malley C, Dowd N. A randomised prospective trial of intra-operative oesophageal Doppler-guided fluid administration in major gynaecological surgery. Anaesthesia. 2013 Dec;68(12):1224-31. doi: 10.1111/anae.12355. Epub 2013 Sep 30.
- Individual participant dataSharing planned: No
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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.
Duygu Akyol principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Akut kidnet injury(AKI) in people with Fluid Overload and Fluid Loss, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of acute kidney injury (time frame: Change from preoperative to postoperative day 1(POD1)creatinine values(mg/dl)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101498, which also lists 5 linked publications.
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 27 Nov 2023.