Fluid ORiented Therapy for yoUNg Asa 1patients

March 20, 2017 updated by: Dr.Andrea Russo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Effects of the Goal-directed Fluid Therapy on ASA 1 Patients Scheduled for Intensive Debulking Surgery

In this retrospective analysis investigators will study the effects of using a minimally invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants will compare a control group to a case group; in both groups ASA 1 patients suffering from advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic was managed by using the FloTrac system; in the control group a standard hemodynamic monitoring was used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA 1

Exclusion Criteria:

  • cardiac diseases
  • pulmonary diseases
  • renal diseases
  • metabolic disorders

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
patients in which standard fluid administration was applied
ACTIVE_COMPARATOR: case group
patients in which fluids were administered according to FloTrac parameters
Device: FloTrac
For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of complications
Time Frame: up to 30 days
up to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
days of hospitalization
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Andrea MD Russo, Department of Anesthesiology

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, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (ACTUAL)

March 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FORTUNA study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

Clinical Trials on Hemodynamics

Clinical Trials on FloTrac

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe