Peroperative Fluid Management in Major Gynecological Cancer Surgeries

November 23, 2023 updated by: Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Basaksehir
      • Istanbul, Basaksehir, Turkey, 3268
        • Başakşehir Çam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional fluid therapy
Patients who received conventional fluid therapy
Diagnostic test: Akut kidnet injury(AKI)
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
Experimental: Non invaziv goal directed therapy
Patients who received non invaziv goal directed therapy
Diagnostic test: Akut kidnet injury(AKI)
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
Experimental: Minimal invaziv goal directed therapy
Patients who received minimal invaziv goal directed therapy
Diagnostic test: Akut kidnet injury(AKI)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from preoperative to postoperative day 1(POD1)creatinine values(mg/dl)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peroperative fluid amounts
Time Frame: during the operation period
The seconder aim to investigate the amount of fluid used peroperatively
during the operation period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensive care unit admission
Time Frame: posoperatively up to 1 months
The other aim to investigate the intensive care unit admission
posoperatively up to 1 months
Length of stay
Time Frame: postoperative 30 days
The other aim to evaluate the duration of hospital stay.
postoperative 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: Duygu Akyol, Basaksehir Cam & Sakura Şehir Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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