Hemodynamic InstabilityINTATNCT03474224
Hemodynamic Optimization During Major Urological Surgery
An observational study of Hemodynamic Instability, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In this prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Ev1000 Clinical Platform from Edwards Lifesciences
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2018to 28 Jul 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for major urological surgery who met the above mentioned inclusion criteria will be enrolled. All patients will belong the only study group in which a target-based hemodynamic protocol will be applied
Who may be able to join
- patients scheduled for major urological surgery
- ASA 1-2-3
Who cannot join
- pregnancy
- obesity with a BMI > 35
- controindications to central venous catheter positioning
- end-stage renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between IN-TArget Time for Mean Arterial Pressure and Stroke Volume During Major Urological Surgery and Tissue Perfusion: the INTAT Observational Study
In this prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP).
Read the detailed description
During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and vasopressors administration. More specifically stroke volume target will be defined as the maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect to find an inverse proportionality between the two parameters explored.
- Conditions
- Hemodynamic Instability
- Being tested
- Ev1000 Clinical Platform from Edwards Lifesciences
- Keywords
- stroke volume, goal directed therapy, major urological surgery, mean arterial pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ev1000 Clinical Platform from Edwards LifesciencesDevice
The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.
| Study group | Role | What they receive |
|---|---|---|
| FloTrac patients | patients belong to this group will be managed with a stroke volume target hemodynamic protocol Receives: Device: Ev1000 Clinical Platform from Edwards Lifesciences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the time-in target of MAP and the pCO2 gap at the end of surgery
The primary outcome will explore the hypothesis that patient with higher adherence of MAP levels above 65 mmHg will have a lower pCO2 gap at the end of surgery
Measured: an average of 8 hours
Correlation between the time-in target of SV and the pCO2 gap at the end of surgery
The co-primary outcome will explore the hypothesis that patient with higher adherence of SV within the maximum value with a 10% tolerance, will have a lower pCO2 gap at the end of surgery
Measured: an average of 8 hours
Secondary outcomes (2)
incidence of postoperative overall complications
investigators will assess the impact of the intraoperative hemodynamic optimization on the rate of postoperative complications
Measured: up to 30 days
duration of hospitalization
investigators will prospectively evaluate the association between an intraoperative goal-directed fluid therapy with the long of stay
Measured: an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start5 Oct 2018
- Primary completion21 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Andrea Russo, MD, Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474224
- Sponsor's protocol ID
- 1822
- Acronym
- INTAT
- Status last verified
- Jun 2022
- First submitted
- 25 Feb 2018
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between IN-TArget Time for Mean Arterial Pressure and Stroke Volume During Major Urological Surgery and Tissue Perfusion: the INTAT Observational Study
- ClinicalTrials.gov ID
- NCT03474224
- Acronym / sponsor ID
- INTAT / 1822
- Conditions
- Hemodynamic Instability
- Keywords
- stroke volume, goal directed therapy, major urological surgery, mean arterial pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 22 Mar 2018 (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 prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP).
Detailed description
During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and vasopressors administration. More specifically stroke volume target will be defined as the maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect to find an inverse proportionality between the two parameters explored.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FloTrac patients | – | Device: Ev1000 Clinical Platform from Edwards Lifesciencespatients belong to this group will be managed with a stroke volume target hemodynamic protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for major urological surgery who met the above mentioned inclusion criteria will be enrolled. All patients will belong the only study group in which a target-based hemodynamic protocol will be applied
Key inclusion criteria (2 listed)
- patients scheduled for major urological surgery
- ASA 1-2-3
Key exclusion criteria (4 listed)
- pregnancy
- obesity with a BMI > 35
- controindications to central venous catheter positioning
- end-stage renal disease
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 |
|---|---|---|
| Ev1000 Clinical Platform from Edwards LifesciencesThe EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume. | Device | FloTrac patients |
Primary outcome
Correlation between the time-in target of MAP and the pCO2 gap at the end of surgery
Time frame: an average of 8 hours
The primary outcome will explore the hypothesis that patient with higher adherence of MAP levels above 65 mmHg will have a lower pCO2 gap at the end of surgery
Correlation between the time-in target of SV and the pCO2 gap at the end of surgery
Time frame: an average of 8 hours
The co-primary outcome will explore the hypothesis that patient with higher adherence of SV within the maximum value with a 10% tolerance, will have a lower pCO2 gap at the end of surgery
2 secondary outcomes
incidence of postoperative overall complications
Time frame: up to 30 days
duration of hospitalization
Time frame: an average of 2 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 7 Jun 2022.
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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 Russo, MD principal investigator
Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 2 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 7 Jun 2022. 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?
Correlation between the time-in target of MAP and the pCO2 gap at the end of surgery (time frame: an average of 8 hours). The study lists 2 primary outcomes in all. 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 Jun 2022.