Fluid ORiented Therapy for yoUNg Asa 1patients

Overview

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.

Full Title of Study: “Effects of the Goal-directed Fluid Therapy on ASA 1 Patients Scheduled for Intensive Debulking Surgery”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: July 2015

Interventions

• Device: FloTrac
  • For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration

Arms, Groups and Cohorts

• 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

Clinical Trial Outcome Measures

Primary Measures

• prevalence of complications
  • Time Frame: up to 30 days

Secondary Measures

• days of hospitalization
  • Time Frame: up to 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

• ASA 1 Exclusion Criteria:

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Provider of Information About this Clinical Study
  • Principal Investigator: Dr.Andrea Russo, Medical Doctor – Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Overall Official(s)
  • Andrea MD Russo, Principal Investigator, Department of Anesthesiology