Clinical trial NCT06101498: Peroperative Fluid Management in Major Gynecological Cancer Surgeries
Official title: The Effect of Peroperative Fluid Management Strategy on Postoperative Renal Functions in Major Gyneco-oncological Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-26
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* ASA II-III
* Those with normal renal function

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of acute kidney injury
timeFrame: Change from preoperative to postoperative day 1(POD1)creatinine values(mg/dl)
Secondary outcomes:
measure: Peroperative fluid amounts
timeFrame: during the operation period
Other outcomes:
measure: The intensive care unit admission
timeFrame: posoperatively up to 1 months
measure: Length of stay
timeFrame: postoperative 30 days
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
state: Basaksehir
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Duygu Akyol
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yu 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.
citation: Russo 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.
citation: Hasselgren 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.
citation: McKenny 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.