SurgeryBRAINPROMISENCT04266574
BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
A study testing Near Infrared Spectroscopy (NIRS) in people with Surgery and Perioperative Complication, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Perioperative Complication
- What is being tested?
- Near Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 17 Nov 2020to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5
- presence of an arterial catheter during anesthesia
- planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia
- ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations
Who cannot join
- Unable to consent to study inclusion
- Language barrier
- Severe neurological or psychiatric disease
- End-stage dementia
- Total Intravenous anesthesia
- No use of hypertensive medication at home.
Trial locations and contacts
1 site in 1 country.
Massimiliano Greco, MD contact
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, Milan, 20089
Maurizio Cecconi, MD
About this study
The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.
Read the detailed description
Background:
Perioperative complications lead to impaired quality of life as well as prolonged disability. In high risk patients, early hemodynamic optimization with the goal of achieving and maintaining tissue oxygenation in the perioperative period has resulted in an improvement of outcomes and a reduction in surgery-related complications. Maintenance of adequate oxygen delivery to tissue, is one of the fundamental aspects of anesthesia. Regional Oxygen Saturation of the brain tissue (rSO2) as measured by near-infrared spectroscopy (NIRS) is a promising tool in vascular surgery and cardiac surgery for the monitoring of global cerebral perfusion.
Objectives:
This study has the purpose to assess whether an rSO2-based hemodynamic optimization algorithm is able to reduce overall perioperative complications in high risk patients.
Design:
BRAIN-PROMISE is a monocentric, randomized controlled trial.
Population:
Hypertensive elderly or frail patients undergoing major surgery.
Experimental Intervention:
Cases will be managed using a NIRS-targeted goal directed therapy.
Control Intervention:
Controls will be managed according to standard care.
Outcomes:
The primary outcome are the incidence of perioperative complications at 30 days and the percentage of successful reversal of reduction in NIRS.
Trial size:
A total of 200 patients will be randomized.
- Conditions
- Surgery, Perioperative Complication
- Being tested
- Near Infrared Spectroscopy (NIRS), Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy (NIRS)Device
The anesthesiologist will apply optodes before induction of anesthesia and before preoxygenation, to detect baseline NIRS level, NIRS will be monitored continuously up to post-anaesthesia care unit (PACU) discharge, or up to three the investigator's after ICU admission.
When a decrease in NIRS value over 10% is detected, or if NIRS value is below 60%, patients will start hemodynamic optimization, to reverse the reduction in NIRS and return to baseline values, according to a predefined protocol.
Standard CareDevice
Controls will be treated according to standard of care, maintaining a MAP≥65 and an adequate cardiac output according to the hemodynamic monitoring chosen by the anesthesiologist (invasive blood pressure monitoring or pulse contour monitors). NIRS will be recorded also in controls, but caring anesthesiologists will be blinded to NIRS.
| Study group | Role | What they receive |
|---|---|---|
| Near Infrared Spectroscopy (NIRS) | Experimental | Not described Receives: Device: Near Infrared Spectroscopy (NIRS) |
| Standard Care | Active comparator | Not described Receives: Device: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall incidence of perioperative complications (including postoperative cognitive dysfunction and delirium).
Measured: 30 day after randomization
Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.
Measured: intraoperative
Secondary outcomes (7)
NIRS variations over time, and according to interventions
Measured: intraoperative
Percentage of time with NIRS within safety limits (<10% reduction)
Measured: intraoperative
Bispectral index (BIS) over time
Measured: intraoperative
Mean arterial pressure (MAP) over time
Measured: intraoperative
sevorane concentration over time
Measured: intraoperative
Use of vasopressors and fluids to maintain MAP
Measured: intraoperative
Evaluate fluid administration
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start17 Nov 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Cecconi, Prof, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266574
- Sponsor's protocol ID
- 1211
- Acronym
- BRAINPROMISE
- Status last verified
- Oct 2024
- First submitted
- 10 Feb 2020
- Last updated
- 23 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greco M, Calgaro G, Cavallo M, Pugliese S, Mascari M, Piccirillo F, Pradella A, Piccioni F, Cecconi M. Brain-targeted goal-directed therapy in high-risk patients undergoing major elective surgery: Study protocol for the BRAIN-PROMISE randomized trial. Contemp Clin Trials. 2025 Jul;154:107940. doi: 10.1016/j.cct.2025.107940. Epub 2025 May 4.
PubMed 40328360
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
- ClinicalTrials.gov ID
- NCT04266574
- Acronym / sponsor ID
- BRAINPROMISE / 1211
- Conditions
- Surgery, Perioperative Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Feb 2020 (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.
The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.
Detailed description
Background:
Perioperative complications lead to impaired quality of life as well as prolonged disability. In high risk patients, early hemodynamic optimization with the goal of achieving and maintaining tissue oxygenation in the perioperative period has resulted in an improvement of outcomes and a reduction in surgery-related complications. Maintenance of adequate oxygen delivery to tissue, is one of the fundamental aspects of anesthesia. Regional Oxygen Saturation of the brain tissue (rSO2) as measured by near-infrared spectroscopy (NIRS) is a promising tool in vascular surgery and cardiac surgery for the monitoring of global cerebral perfusion.
Objectives:
This study has the purpose to assess whether an rSO2-based hemodynamic optimization algorithm is able to reduce overall perioperative complications in high risk patients.
Design:
BRAIN-PROMISE is a monocentric, randomized controlled trial.
Population:
Hypertensive elderly or frail patients undergoing major surgery.
Experimental Intervention:
Cases will be managed using a NIRS-targeted goal directed therapy.
Control Intervention:
Controls will be managed according to standard care.
Outcomes:
The primary outcome are the incidence of perioperative complications at 30 days and the percentage of successful reversal of reduction in NIRS.
Trial size:
A total of 200 patients will be randomized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near Infrared Spectroscopy (NIRS) | Experimental | Device: Near Infrared Spectroscopy (NIRS) |
| Standard Care | Active comparator | Device: Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5
- presence of an arterial catheter during anesthesia
- planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia
- ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations
Key exclusion criteria (6 listed)
- Unable to consent to study inclusion
- Language barrier
- Severe neurological or psychiatric disease
- End-stage dementia
- Total Intravenous anesthesia
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 |
|---|---|---|
| Near Infrared Spectroscopy (NIRS)The anesthesiologist will apply optodes before induction of anesthesia and before preoxygenation, to detect baseline NIRS level, NIRS will be monitored continuously up to post-anaesthesia care unit (PACU) discharge, or up to three the investigator's after ICU admission. When a decrease in NIRS value over 10% is detected, or if NIRS value is below 60%, patients will start hemodynamic optimization, to reverse the reduction in NIRS and return to baseline values, according to a predefined protocol. | Device | Near Infrared Spectroscopy (NIRS) |
| Standard CareControls will be treated according to standard of care, maintaining a MAP≥65 and an adequate cardiac output according to the hemodynamic monitoring chosen by the anesthesiologist (invasive blood pressure monitoring or pulse contour monitors). NIRS will be recorded also in controls, but caring anesthesiologists will be blinded to NIRS. | Device | Standard Care |
Primary outcome
The overall incidence of perioperative complications (including postoperative cognitive dysfunction and delirium).
Time frame: 30 day after randomization
Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.
Time frame: intraoperative
7 secondary outcomes
NIRS variations over time, and according to interventions
Time frame: intraoperative
Percentage of time with NIRS within safety limits (<10% reduction)
Time frame: intraoperative
Bispectral index (BIS) over time
Time frame: intraoperative
Mean arterial pressure (MAP) over time
Time frame: intraoperative
sevorane concentration over time
Time frame: intraoperative
Use of vasopressors and fluids to maintain MAP
Time frame: intraoperative
Evaluate fluid administration
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 40328360Greco M, Calgaro G, Cavallo M, Pugliese S, Mascari M, Piccirillo F, Pradella A, Piccioni F, Cecconi M. Brain-targeted goal-directed therapy in high-risk patients undergoing major elective surgery: Study protocol for the BRAIN-PROMISE randomized trial. Contemp Clin Trials. 2025 Jul;154:107940. doi: 10.1016/j.cct.2025.107940. Epub 2025 May 4.
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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.
Massimiliano Greco, MD contact
Maurizio Cecconi, Prof, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near Infrared Spectroscopy (NIRS) in people with Surgery and Perioperative Complication, run by Istituto Clinico Humanitas 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 4 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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurizio Cecconi, Prof, MD (0282244115, maurizio.cecconi@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall incidence of perioperative complications (including postoperative cognitive dysfunction and delirium). (time frame: 30 day after randomization). 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?
On the ClinicalTrials.gov record for NCT04266574, which also lists 1 linked publication.
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 23 Oct 2024.