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OpenTrials
Completed

NCT Number: NCT06101498

Peroperative Fluid Management in Major Gynecological Cancer 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.

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Key information

Conditions

Fluid Overload Acute Kidney Injury Edema Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fluid Loss Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, 3268, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Akut kidnet injury(AKI)

Diagnostic Test

postoperative 24 hours

Other names: 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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Peroperative fluid amounts

    Time frame: during the operation period

    The seconder aim to investigate the amount of fluid used peroperatively

Other outcomes

  1. The intensive care unit admission

    Time frame: posoperatively up to 1 months

    The other aim to investigate the intensive care unit admission

  2. Length of stay

    Time frame: postoperative 30 days

    The other aim to evaluate the duration of hospital stay.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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