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NCT Number: NCT04266574

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

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Key information

Conditions

Surgery Perioperative Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location status: Recruiting

Location contact

Maurizio Cecconi, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 30 day after randomization

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

    Time frame: intraoperative

Secondary outcomes

  1. NIRS variations over time, and according to interventions

    Time frame: intraoperative

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

    Time frame: intraoperative

  3. Bispectral index (BIS) over time

    Time frame: intraoperative

  4. Mean arterial pressure (MAP) over time

    Time frame: intraoperative

  5. sevorane concentration over time

    Time frame: intraoperative

  6. Use of vasopressors and fluids to maintain MAP

    Time frame: intraoperative

  7. Evaluate fluid administration

    Time frame: intraoperative

Study contacts

Contact information is provided by the study sponsor or research team.

Massimiliano Greco, MD

CONTACT

[email protected]

Maurizio Cecconi, Prof, MD

CONTACT

[email protected]

0282244115

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Acronym: BRAINPROMISE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2020
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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