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Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

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ClinicalTrials.gov Identifier: NCT01995786
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute

Study Description
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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

Study Design
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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
Arms and Interventions
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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


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

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

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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01995786


Locations
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Italy
Regina Elena CI
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
Investigators
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Principal Investigator: Ester Forastiere Regina Elena CI
More Information
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Responsible Party: Ester Forastiere, chief, Regina Elena Cancer Institute
ClinicalTrials.gov 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
Hemodynamics
Cost Control
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes