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NCT01995786 Clinical Trial

Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

Postoperative Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01995786
Other study ID # 19.11
Secondary ID
Status Completed
Phase N/A
First received November 21, 2013
Last updated April 6, 2016
Start date January 2012

Study information
Verified date April 2016
Source Regina Elena Cancer Institute
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Device:
• Goal Directed Fluid Therapy FloTrac/Vigileo

Locations
Country Name City State
Italy Regina Elena CI Rome

Sponsors (1)
Lead Sponsor Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of reduction of postoperative spending 30 day postoperative No
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