Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

Regina Elena Cancer Institute

Status: Completed

Conditions: Postoperative Complications

Treatments: Device: Goal Directed Fluid Therapy FloTrac/Vigileo

Study type: Interventional

Funder types: Other

Identifiers

NCT01995786

19.11

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Conventional Intravenous Fluid therapy

No Intervention group

Description:

Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour

GDT

Experimental group

Description:

Basal 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

Treatment:

Device: Goal Directed Fluid Therapy FloTrac/Vigileo