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Clinical Trials/NCT03090399
NCT03090399CompletedNot Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 sites60 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Primary Endpoint
prevalence of complications

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Arms & Interventions

control group

No Intervention

patients in which standard fluid administration was applied

case group

Active Comparator

patients in which fluids were administered according to FloTrac parameters

Intervention: FloTrac (Device)

Outcomes

Primary Outcomes

prevalence of complications

Time Frame: up to 30 days

Secondary Outcomes

  • days of hospitalization(up to 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr.Andrea Russo

Medical Doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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