Goal Directed Fluid Therapy (FLO1)

October 17, 2018 updated by: Andrea Holzer, Medical University of Vienna

Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients

Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI <25) vs. obese patients (BMI >25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

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

  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)

Exclusion Criteria:

  • cardiac insufficiency (EF< 35%)
  • renal insufficiency (creatinin clearance <30ml/min, dialysis)
  • insulin dependant diabetes mellitus
  • coagulopathy
  • NYHA IV
  • infection
  • sepsis
  • history of suspect malignant hyperthermia
  • porphyria

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ringerlactate lean
fluidtherapy with crystalloids in lean patients
Drug: fluidotherapy with ringer-lactate
a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler
Active Comparator: Ringerlactate overweight
fluidtherapy with crystalloids in overweight patients
Drug: fluidotherapy with ringer-lactate
a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler
Active Comparator: Ringerlactate obese
fluidtherapy with crystalloids in obese patients
Drug: fluidotherapy with ringer-lactate
a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
different hemodynamic fluid responses in the different groups
Time Frame: every 10 minutes during surgery
every 10 minutes during surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Subcutaneous oxygen tension (PsqO2)
Time Frame: every 10 minutes during surgery and 2 hours postoperatively
every 10 minutes during surgery and 2 hours postoperatively

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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

November 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EK 299/2006

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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