Peroperative Fluid Management in Major Gynecological Cancer Surgeries

Acute Kidney Injury Clinical Trial

Official title:

The Effect of Peroperative Fluid Management Strategy on Postoperative Renal Functions in Major Gyneco-oncological Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06101498
• Other study ID #: 2023.478
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Fluid Loss
• Fluid Overload
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Diagnostic Test:
• Akut kidnet injury(AKI)
postoperative 24 hours

Locations

Country	Name	City	State
Turkey	Basaksehir Çam and Sakura City Hospital	Istanbul	Basaksehir

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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 — View 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 — View 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 medicin — View 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.2 — View 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. eCollecti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The intensive care unit admission	The other aim to investigate the intensive care unit admission	posoperatively up to 1 months
Other	Length of stay	The other aim to evaluate the duration of hospital stay.	postoperative 30 days
Primary	Evaluation of acute kidney injury	Our primary aim was to evaluate the postoperative day(POD1 ) creatinine values(mg/dl)	Change from preoperative to postoperative day 1(POD1)creatinine values(mg/dl)
Secondary	Peroperative fluid amounts	The seconder aim to investigate the amount of fluid used peroperatively	during the operation period