Hemodynamic (MAP) StabilitySIMPLYNCT07366164
Hemodynamic Optimization Using an Artificial Intelligenze System
A study testing assisted fluid therapy in people with Hemodynamic (MAP) Stability and Fluid Management, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study will investigate the impact of using an automated fluid management system on intraoperative fluid therapy in patients undergoing colorectal surgery. The aim is to evaluate whether automated guidance can optimize hemodynamic stability and reduce the incidence of arterial hypotension, Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic (MAP) Stability, Fluid Management
- What is being tested?
- assisted fluid therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 >18 years old and ASA 3 scheduled for laparoscopic colorectal surgery
Who cannot join
- Refusal of consent
- Body Mass Index > 35 kg/m2
- urgent cases
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paola Aceto, professor contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Policlinico Gemelli
Roma, RM, 00166
andrea russo, 3333926815, andrea.russo@policlinicogemelli.it
About this study
Official title: The Assisted Fluid Management For High-Risk Patients During Colorectal Surgery: A Randomised Controlled Clinical Trial
This study will investigate the impact of using an automated fluid management system on intraoperative fluid therapy in patients undergoing colorectal surgery. The aim is to evaluate whether automated guidance can optimize hemodynamic stability and reduce the incidence of arterial hypotension,
- Conditions
- Hemodynamic (MAP) Stability, Fluid Management
- Being tested
- assisted fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assisted fluid therapyDevice
for this intervention, fluids will be administered using an assisted fluid device
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | fluid therpay fo this grioup will be giuded through the assisted fluid management system Receives: Device: assisted fluid therapy |
| control group | No intervention | patients belonging to this group will receive fluids following a standard hemodynamic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
amounts of fluids
we registered and compared the amounts of administered fluids after surgery
Measured: at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Oct 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic (MAP) StabilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
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, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366164
- Sponsor's protocol ID
- 7755
- Acronym
- SIMPLY
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assisted Fluid Management For High-Risk Patients During Colorectal Surgery: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07366164
- Acronym / sponsor ID
- SIMPLY / 7755
- Conditions
- Hemodynamic (MAP) Stability, Fluid Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 26 Jan 2026 (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.
This study will investigate the impact of using an automated fluid management system on intraoperative fluid therapy in patients undergoing colorectal surgery. The aim is to evaluate whether automated guidance can optimize hemodynamic stability and reduce the incidence of arterial hypotension,
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: assisted fluid therapyfluid therpay fo this grioup will be giuded through the assisted fluid management system |
| control group | No intervention | –patients belonging to this group will receive fluids following a standard hemodynamic 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)
- patients >18 years old and ASA 3 scheduled for laparoscopic colorectal surgery
Key exclusion criteria (4 listed)
- Refusal of consent
- Body Mass Index > 35 kg/m2
- urgent cases
- pregnancy
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 |
|---|---|---|
| assisted fluid therapyfor this intervention, fluids will be administered using an assisted fluid device | Device | treatment group |
Primary outcome
amounts of fluids
Time frame: at the end of surgery
we registered and compared the amounts of administered fluids after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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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.
Paola Aceto, professor contact
andrea russo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assisted fluid therapy in people with Hemodynamic (MAP) Stability and Fluid Management, 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 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact andrea russo, medical doctor (+393333926815, russoandreamd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amounts of fluids (time frame: at the end of surgery). 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 26 Jan 2026.