Fluid ORiented Therapy for yoUNg Asa 1patients

Hemodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090399
• Other study ID #: FORTUNA study
• Status: Completed
• Phase: N/A
• First received: January 13, 2017
• Last updated: March 20, 2017
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Policlinico Universitario Agostino Gemelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA 1

Exclusion Criteria:

• cardiac diseases

• pulmonary diseases

• renal diseases

• metabolic disorders

Related Conditions & MeSH terms

• Hemodynamics

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Universitario Agostino Gemelli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of complications		up to 30 days
Secondary	days of hospitalization		up to 12 weeks