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Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01995786
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : April 7, 2016
Information provided by (Responsible Party):
Ester Forastiere, 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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Device: Goal Directed Fluid Therapy FloTrac/Vigileo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Study Start Date : January 2012
Actual Primary Completion Date : December 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. rate of reduction of postoperative spending [ Time Frame: 30 day postoperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01995786

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Regina Elena CI
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
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Principal Investigator: Ester Forastiere Regina Elena CI
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Responsible Party: Ester Forastiere, chief, Regina Elena Cancer Institute Identifier: NCT01995786    
Other Study ID Numbers: 19.11
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Keywords provided by Ester Forastiere, Regina Elena Cancer Institute:
Fluid Therapy
Cost-Benefit Analysis
Cost Control
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes