CClinicalTrials.gg
CompletedNCT01995786Updated Apr 7, 2016

Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

An interventional study of Goal Directed Fluid Therapy FloTrac/Vigileo in Postoperative Complications, sponsored by Regina Elena Cancer Institute. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-07.

Sponsored by Regina Elena Cancer Institute · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Complications

Keywords

  • Fluid Therapy
  • Cost-Benefit Analysis
  • Hemodynamics
  • Cost Control
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 200 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Regina Elena Cancer Institute is the lead sponsor of 92 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients selected for major abdominal surgery

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • No intervention
    Conventional Intravenous Fluid therapy

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

  • Experimental
    GDT

    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

    Device: Goal Directed Fluid Therapy FloTrac/Vigileo

Interventions

  • DeviceGoal Directed Fluid Therapy FloTrac/Vigileo
06

What researchers measure

Primary outcomes

  1. rate of reduction of postoperative spending

    Time frame: 30 day postoperative

07

Study locations

1 site
  • Regina Elena CI
    Rome, 00144, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01995786
Lead sponsor
Regina Elena Cancer Institute
Responsible party
Ester Forastiere (chief, Regina Elena Cancer Institute) — Principal investigator
First posted
Nov 27, 2013
Start date
Jan 2012
Primary completion
Dec 2014
Last update
Apr 7, 2016

Study contacts

Ester Forastiere
principal investigator · Regina Elena CI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion