Postoperative ComplicationsNCT01995786
Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy
A study testing Goal Directed Fluid Therapy FloTrac/Vigileo in people with Postoperative Complications, run by Regina Elena Cancer Institute at 1 site in Italy.
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®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Goal Directed Fluid Therapy FloTrac/Vigileo
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients selected for major abdominal surgery
Who cannot join
- •Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postoperative Complications
- Being tested
- Goal Directed Fluid Therapy FloTrac/Vigileo
- Keywords
- Fluid Therapy, Cost-Benefit Analysis, Hemodynamics, Cost Control
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Directed Fluid Therapy FloTrac/VigileoDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Goal Directed Fluid Therapy FloTrac/Vigileo |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of reduction of postoperative spending
Measured: 30 day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, Regina Elena Cancer Institute
- Investigators
- Ester Forastiere, Principal investigator, Regina Elena CI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995786
- Sponsor's protocol ID
- 19.11
- Status last verified
- Apr 2016
- First submitted
- 21 Nov 2013
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy
- ClinicalTrials.gov ID
- NCT01995786
- Acronym / sponsor ID
- 19.11
- Conditions
- Postoperative Complications
- Keywords
- Fluid Therapy, Cost-Benefit Analysis, Hemodynamics, Cost Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Goal Directed Fluid Therapy FloTrac/VigileoBasal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients selected for major abdominal surgery
Key exclusion criteria (1 listed)
- •Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Directed Fluid Therapy FloTrac/Vigileo | Device | GDT |
Primary outcome
rate of reduction of postoperative spending
Time frame: 30 day postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ester Forastiere principal investigator
Regina Elena CI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Directed Fluid Therapy FloTrac/Vigileo in people with Postoperative Complications, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of reduction of postoperative spending (time frame: 30 day postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.