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

Surgery Clinical Trial

— BRAINPROMISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04266574
• Other study ID #: 1211
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Istituto Clinico Humanitas
• Contact: Maurizio Cecconi, Prof, MD
• Phone: 0282244115
• Email: maurizio.cecconi[@]hunimed.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hypertensive patients with American Society of Anesthesiologists (ASA) score= 3 with either Age = 80 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 2 hours, in general anesthesia

• ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations

Exclusion Criteria:

• Age < 80 years

• Unable to consent to study inclusion

• Language barrier

• Severe neurological or psychiatric disease

• End-stage dementia

• Total Intravenous anesthesia

• Trendelenburg positioning

• No hypertensive medication

Related Conditions & MeSH terms

• Perioperative Complication
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall incidence of perioperative complications (including postoperative cognitive dysfunction and delirium).		30 day after randomization
Primary	Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.		intraoperative
Secondary	NIRS variations over time, and according to interventions		intraoperative
Secondary	Percentage of time with NIRS within safety limits (<10% reduction)		intraoperative
Secondary	Bispectral index (BIS) over time		intraoperative
Secondary	Mean arterial pressure (MAP) over time		intraoperative
Secondary	sevorane concentration over time		intraoperative
Secondary	Use of vasopressors and fluids to maintain MAP		intraoperative
Secondary	Evaluate fluid administration		intraoperative