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
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Condition or disease | Intervention/treatment | Phase |
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Postoperative Complications | Device: Goal Directed Fluid Therapy FloTrac/Vigileo | Not Applicable |
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 |
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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
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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
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Device: Goal Directed Fluid Therapy FloTrac/Vigileo |
- rate of reduction of postoperative spending [ Time Frame: 30 day postoperative ]

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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

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
Italy | |
Regina Elena CI | |
Rome, Italy, 00144 |
Principal Investigator: | Ester Forastiere | Regina Elena CI |
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 |
Fluid Therapy Cost-Benefit Analysis Hemodynamics Cost Control |
Postoperative Complications Pathologic Processes |