Peroperative Fluid Management in Major Gynecological Cancer Surgeries

NCT06101498 | Completed

• 1 other identifier: 2023.478
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Peroperative fluid amounts

  during the operation period

Other Outcomes (2)

• The intensive care unit admission

  posoperatively up to 1 months

• Length of stay

  postoperative 30 days

Study Arms (3)

Conventional fluid therapy

EXPERIMENTAL

Patients who received conventional fluid therapy

Diagnostic Test: Akut kidnet injury(AKI)

Non invaziv goal directed therapy

EXPERIMENTAL

Patients who received non invaziv goal directed therapy

Diagnostic Test: Akut kidnet injury(AKI)

Minimal invaziv goal directed therapy

EXPERIMENTAL

Patients who received minimal invaziv goal directed therapy

Diagnostic Test: Akut kidnet injury(AKI)

Interventions

Akut kidnet injury(AKI) DIAGNOSTIC_TEST

postoperative 24 hours

Also known as: 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

Conventional fluid therapy; Minimal invaziv goal directed therapy; Non invaziv goal directed therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, 3268, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 35121063 RESULT

• 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.

  PMID: 35463383 RESULT

• 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.

  PMID: 30201234 RESULT

• 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.

  PMID: 33715894 RESULT

• 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.

  PMID: 24116747 RESULT

MeSH Terms

Conditions

Edema; Postoperative Complications; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Duygu Akyol

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)