Goal Directed TherapyNCT03023618
Fluid Oriented Therapy During Major Abdominal Surgery
A study testing FloTrac in people with Goal Directed Therapy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
In this "before and after" study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Goal Directed Therapy
- What is being tested?
- FloTrac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2016
- 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
- ASA 1-2 patients
Who cannot join
- Severe Caridiac Disease
- Renal Failure
About this study
Official title: Effect Of Stroke Volume Optimization On Complication Rate Of Patients Undergoing Pancreatic Surgery
In this "before and after" study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). In the postoperative period overall complications, as well as exitus , will be analyzed and compared with those of a control group underwent the same surgical interventions, with a standard hemodynamic monitoring.
- Conditions
- Goal Directed Therapy
- Being tested
- FloTrac
- Keywords
- [G09.330.380]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloTracDevice
Stroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | patients before 2014, in which fluids were administered without FloTrac monitoring |
| case group | Active comparator | patients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol) Receives: Device: FloTrac |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate
Measured: up to 30 days postoperatively
Secondary outcomes (1)
Duration of hospitalization
Measured: an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Goal Directed TherapyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Andrea Russo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Valter MD Perilli, PhD, Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023618
- Sponsor's protocol ID
- PERILLI-NICE
- Status last verified
- Jan 2017
- First submitted
- 1 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Stroke Volume Optimization On Complication Rate Of Patients Undergoing Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT03023618
- Acronym / sponsor ID
- PERILLI-NICE
- Conditions
- Goal Directed Therapy
- Keywords
- [G09.330.380]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Jan 2017 (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.
In this "before and after" study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). In the postoperative period overall complications, as well as exitus , will be analyzed and compared with those of a control group underwent the same surgical interventions, with a standard hemodynamic monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –patients before 2014, in which fluids were administered without FloTrac monitoring |
| case group | Active comparator | Device: FloTracpatients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2 patients
Key exclusion criteria (2 listed)
- Severe Caridiac Disease
- Renal Failure
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 |
|---|---|---|
| FloTracStroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011 | Device | case group |
Primary outcome
complication rate
Time frame: up to 30 days postoperatively
1 secondary outcome
Duration of hospitalization
Time frame: an average of 30 days
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 18 Jan 2017.
- Individual participant dataSharing planned: Yes
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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.
Valter MD Perilli, PhD principal investigator
Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing FloTrac in people with Goal Directed Therapy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 2 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
complication rate (time frame: up to 30 days postoperatively). 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 18 Jan 2017.