Intraoperative Hemodyamic MonitoringREABILITYNCT06164405
Arterial dP/dt Dependency on Loading Conditions
An observational study of Intraoperative Hemodyamic Monitoring, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In the present study the investigators aim to assess the changes of the arterial dP/dtmax induced by fluids and vasoactive drugs during abdominal surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intraoperative Hemodyamic Monitoring
- What is being tested?
- arterial dp/dtmax
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to 10 Mar 2025
- How long will I take part?
- 24 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: surgical patients
Who may be able to join
- patients scheduled for abdominal surgery informed consent acceptance
- -
Who cannot join
- BMI> 30 Kg /m2;
- Atrial Fibrillation;
- Congestive heart failure with FE <35% and/or NYHA≥3;
- Severe known cardiac valve disease;
- Emergency surgery
- Shock or any acute conditions who required admission intensive care unit
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitairo Agostino Gemelli
Roma, RM, 00148
About this study
Official title: RESPONSE OF ARTERIAL dP/dt TO FLUIDS AND VASOACTIVE DRUGS DURING ABDOMINAL SURGERY: A PROSPECTIVE PILOT STUDY
In the present study the investigators aim to assess the changes of the arterial dP/dtmax induced by fluids and vasoactive drugs during abdominal surgery
- Conditions
- Intraoperative Hemodyamic Monitoring
- Being tested
- arterial dp/dtmax
- Keywords
- emodinamica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial dp/dtmaxDevice
to assess the variations of the arterial dp/dt max after drugs or fluids administration
What is being measured
The primary outcome is the main question the study is designed to answer.
dp/dt fluids dependency
measurement of dp/dtmax after fluid challenge
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Hemodyamic MonitoringStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 24 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164405
- Sponsor's protocol ID
- 6166
- Acronym
- REABILITY
- Status last verified
- Apr 2025
- First submitted
- 1 Dec 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESPONSE OF ARTERIAL dP/dt TO FLUIDS AND VASOACTIVE DRUGS DURING ABDOMINAL SURGERY: A PROSPECTIVE PILOT STUDY
- ClinicalTrials.gov ID
- NCT06164405
- Acronym / sponsor ID
- REABILITY / 6166
- Conditions
- Intraoperative Hemodyamic Monitoring
- Keywords
- emodinamica
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 11 Dec 2023 (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 the present study the investigators aim to assess the changes of the arterial dP/dtmax induced by fluids and vasoactive drugs during abdominal surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- surgical patients
Key inclusion criteria (2 listed)
- patients scheduled for abdominal surgery informed consent acceptance
- -
Key exclusion criteria (6 listed)
- BMI> 30 Kg /m2;
- Atrial Fibrillation;
- Congestive heart failure with FE <35% and/or NYHA≥3;
- Severe known cardiac valve disease;
- Emergency surgery
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 |
|---|---|---|
| arterial dp/dtmaxto assess the variations of the arterial dp/dt max after drugs or fluids administration | Device | – |
Primary outcome
dp/dt fluids dependency
Time frame: intraoperative
measurement of dp/dtmax after fluid challenge
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 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Intraoperative Hemodyamic Monitoring
Active, not recruitingObservational study
Intraoperative Perfusion Index and Mortality
Hemodynamic, Perfusion Index
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intraoperative Hemodyamic Monitoring, 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 6 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 8 Apr 2025. 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?
dp/dt fluids dependency (time frame: intraoperative). 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 8 Apr 2025.