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Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Goal Directed Fluid Therapy FloTrac/Vigileo
Sponsored by
Regina Elena Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postoperative Complications focused on measuring Fluid Therapy, Cost-Benefit Analysis, Hemodynamics, Cost Control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regina Elena CI

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional Intravenous Fluid therapy

GDT

Arm Description

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

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

Outcomes

Primary Outcome Measures

rate of reduction of postoperative spending

Secondary Outcome Measures

Full Information

First Posted
November 21, 2013
Last Updated
April 6, 2016
Sponsor
Regina Elena Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01995786
Brief Title
Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Fluid Therapy, Cost-Benefit Analysis, Hemodynamics, Cost Control

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Intravenous Fluid therapy
Arm Type
No Intervention
Arm Description
Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour
Arm Title
GDT
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Goal Directed Fluid Therapy FloTrac/Vigileo
Primary Outcome Measure Information:
Title
rate of reduction of postoperative spending
Time Frame
30 day postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester Forastiere
Organizational Affiliation
Regina Elena CI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regina Elena CI
City
Rome
ZIP/Postal Code
00144
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

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