BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study

NCT04266574 | Recruiting

• 1 other identifier: 1211
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Perioperative Complication

Outcome Measures

Primary Outcomes (2)

• The overall incidence of perioperative complications (including postoperative cognitive dysfunction and delirium).

  30 day after randomization

• Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.

  intraoperative

Secondary Outcomes (7)

• NIRS variations over time, and according to interventions

  intraoperative

• Percentage of time with NIRS within safety limits (<10% reduction)

  intraoperative

• Bispectral index (BIS) over time

  intraoperative

• Mean arterial pressure (MAP) over time

  intraoperative

• sevorane concentration over time

  intraoperative

Study Arms (2)

Near Infrared Spectroscopy (NIRS)

EXPERIMENTAL

Device: Near Infrared Spectroscopy (NIRS)

Standard Care

ACTIVE COMPARATOR

Device: Standard Care

Interventions

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.

Near Infrared Spectroscopy (NIRS)

Standard Care DEVICE

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Language barrier
• Severe neurological or psychiatric disease
• End-stage dementia
• Total Intravenous anesthesia
• No use of hypertensive medication at home.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 40328360 DERIVED

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Maurizio Cecconi, Prof, MD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Cecconi, Prof, MD

CONTACT

0282244115; maurizio.cecconi@hunimed.eu

Massimiliano Greco, MD

CONTACT

massimiliano.greco@hunimed.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: November 17, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

IT (1)