NCT04266574

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	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	Standard Care	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.

Timeline

• Start date: 2020-11-17
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-02-12
• Last updated: 2024-10-23

Locations

1 site across 1 country: Italy