Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fluid ORiented Therapy for yoUNg Asa 1patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090399
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Dr.Andrea Russo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemodynamics Device: FloTrac Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of the Goal-directed Fluid Therapy on ASA 1 Patients Scheduled for Intensive Debulking Surgery
Actual Study Start Date : January 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : January 2017

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




Primary Outcome Measures :
  1. prevalence of complications [ Time Frame: up to 30 days ]

Secondary Outcome Measures :
  1. days of hospitalization [ Time Frame: up to 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090399


Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
Layout table for investigator information
Principal Investigator: Andrea MD Russo Department of Anesthesiology

Layout table for additonal information
Responsible Party: Dr.Andrea Russo, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT03090399     History of Changes
Other Study ID Numbers: FORTUNA study
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Dr.Andrea Russo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Goal Directed Fluid Therapy