Hypotension During SurgeryNCT05481047
Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery
A study testing HPI in people with Hypotension During Surgery and Hemodynamic Instability, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In this study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypotension During Surgery, Hemodynamic Instability
- What is being tested?
- HPI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 22 Mar 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients scheduled for abominal surgery
Who cannot join
- Emergency surgery
- end-stage renal disease
- pregnancy
- obesity
- atrial fibrillation
- previous cerebral ischaemia
- central nervous system disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitairo Agostino Gemelli
Roma, RM, 00148
About this study
Official title: Arterial Hypotension and Regional Cerebral Oxygen Saturation During Major Abdominal Surgery. A Randomized Controlled Trial
In this study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. In this last group arterial hypotension will be avoided based on a HPI (Hypotension Predictive Index) protocol. In the control group arterial hypotension will be promptly treated according to hemodynamic variables.
- Being tested
- HPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPIDevice
based on HPI values, clinicians will administer drugs or fluids in order to avoid arterial hypotension
| Study group | Role | What they receive |
|---|---|---|
| prevention | Experimental | investigator will prevent intraoperative arterial hypotension based on HPI index Receives: Device: HPI |
| treatment | No intervention | investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral tissue oximetry
the difference among the two groups of the percentage value of the median value of Cerebral Oxygen Saturation measured by the near-nfrared spectroscopic technology (Foresight sensor)
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2023
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Andrea Russo, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481047
- Sponsor's protocol ID
- 5079
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Hypotension and Regional Cerebral Oxygen Saturation During Major Abdominal Surgery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05481047
- Acronym / sponsor ID
- 5079
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 1 Aug 2022 (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 study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. In this last group arterial hypotension will be avoided based on a HPI (Hypotension Predictive Index) protocol. In the control group arterial hypotension will be promptly treated according to hemodynamic variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prevention | Experimental | Device: HPIinvestigator will prevent intraoperative arterial hypotension based on HPI index |
| treatment | No intervention | –investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patients scheduled for abominal surgery
Key exclusion criteria (7 listed)
- Emergency surgery
- end-stage renal disease
- pregnancy
- obesity
- atrial fibrillation
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 |
|---|---|---|
| HPIbased on HPI values, clinicians will administer drugs or fluids in order to avoid arterial hypotension | Device | prevention |
Primary outcome
Cerebral tissue oximetry
Time frame: immediately after surgery
the difference among the two groups of the percentage value of the median value of Cerebral Oxygen Saturation measured by the near-nfrared spectroscopic technology (Foresight sensor)
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 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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
Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPI in people with Hypotension During Surgery and 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 1 inclusion and 7 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 5 Feb 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?
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?
Cerebral tissue oximetry (time frame: immediately after 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 5 Feb 2026.