HemodynamicsNCT03090399
Fluid ORiented Therapy for yoUNg Asa 1patients
A study testing FloTrac in people with Hemodynamics, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
In this retrospective analysis investigators will study the effects of using a minimally invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants will compare a control group to a case group; in both groups ASA 1 patients suffering from advanced ovarian cancer underwent radical… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hemodynamics
- What is being tested?
- FloTrac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2017
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1
Who cannot join
- cardiac diseases
- pulmonary diseases
- renal diseases
- metabolic disorders
About this study
Official title: Effects of the Goal-directed Fluid Therapy on ASA 1 Patients Scheduled for Intensive Debulking Surgery
In this retrospective analysis investigators will study the effects of using a minimally invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants will compare a control group to a case group; in both groups ASA 1 patients suffering from advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic was managed by using the FloTrac system; in the control group a standard hemodynamic monitoring was used.
- Conditions
- Hemodynamics
- Being tested
- FloTrac
- Keywords
- Goal Directed Fluid Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloTracDevice
For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | patients in which standard fluid administration was applied |
| case group | Active comparator | patients in which fluids were administered according to FloTrac parameters Receives: Device: FloTrac |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of complications
Measured: up to 30 days
Secondary outcomes (1)
days of hospitalization
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startJan 2012
- Primary completionJul 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- Andrea MD Russo, Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090399
- Sponsor's protocol ID
- FORTUNA study
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2017
- Last updated
- 24 Mar 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 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Goal-directed Fluid Therapy on ASA 1 Patients Scheduled for Intensive Debulking Surgery
- ClinicalTrials.gov ID
- NCT03090399
- Acronym / sponsor ID
- FORTUNA study
- Conditions
- Hemodynamics
- Keywords
- Goal Directed Fluid Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Mar 2017 (actual)
- 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 retrospective analysis investigators will study the effects of using a minimally invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants will compare a control group to a case group; in both groups ASA 1 patients suffering from advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic was managed by using the FloTrac system; in the control group a standard hemodynamic monitoring was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –patients in which standard fluid administration was applied |
| case group | Active comparator | Device: FloTracpatients in which fluids were administered according to FloTrac parameters |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1
Key exclusion criteria (4 listed)
- cardiac diseases
- pulmonary diseases
- renal diseases
- metabolic 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 |
|---|---|---|
| FloTracFor patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration | Device | case group |
Primary outcome
prevalence of complications
Time frame: up to 30 days
1 secondary outcome
days of hospitalization
Time frame: up to 12 weeks
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 24 Mar 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.
Andrea MD Russo principal investigator
Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing FloTrac in people with Hemodynamics, 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 4 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 24 Mar 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?
prevalence of complications (time frame: up to 30 days). 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 24 Mar 2017.