NCT01995786

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

2.9 years

First QC Date

November 21, 2013

Last Update Submit

April 6, 2016

Conditions

Postoperative Complications

Keywords

Fluid TherapyCost-Benefit AnalysisHemodynamicsCost Control

Outcome Measures

Primary Outcomes (1)

  • rate of reduction of postoperative spending

    30 day postoperative

Study Arms (2)

Conventional Intravenous Fluid therapy

NO INTERVENTION

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

GDT

EXPERIMENTAL

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

Interventions

Goal Directed Fluid Therapy FloTrac/VigileoDEVICE
GDT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients selected for major abdominal surgery

You may not qualify if:

  • Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Elena CI

Rome, Italy, 00144, Italy

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ester Forastiere

    Regina Elena CI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

IT(1)