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Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

Not Applicable
Completed
Conditions
Postoperative Complications
Interventions
Device: Goal Directed Fluid Therapy FloTrac/Vigileo
Registration Number
NCT01995786
Lead Sponsor
Regina Elena Cancer Institute
Brief Summary

The aim of the study is to evaluate clinical and economic impact of Goal Directed Fluid Therapy according to NICE haemodynamic protocol. Haemodynamic parameters were assessed using automated pulse contour analysis (Flotrac/Vigileo®). A specific dedicated software has been developed to perform clinical and expenditures data collection, both retrospective and prospective data are archived.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria
  • Patients selected for major abdominal surgery
Exclusion Criteria

•Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
GDTGoal Directed Fluid Therapy FloTrac/VigileoBasal infusion of crystalloids (normal saline,Ringer's lactate,Ringer's solution) at 2,5 ml/kg/h and boluses of crystalloids for values of stroke volume (SV) \< SV TRIGGER. Every additional infusion of colloids, blood derivates, drugs must be recorded
Primary Outcome Measures
NameTimeMethod
rate of reduction of postoperative spending30 day postoperative
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Regina Elena CI

🇮🇹

Rome, Italy

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