NCT04266574 BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
| NCT ID | NCT04266574 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-11-17 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2020-11-17 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Maurizio Cecconi, Prof, MD
PRINCIPAL INVESTIGATOR
Humanitas Research Hospital IRCCS, Rozzano-Milan
Frequently Asked Questions
Who can join the NCT04266574 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04266574 currently recruiting?
Yes, NCT04266574 is actively recruiting participants. Contact the research team at maurizio.cecconi@hunimed.eu for enrollment information.
Where is the NCT04266574 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT04266574 clinical trial?
NCT04266574 is sponsored by Istituto Clinico Humanitas. The principal investigator is Maurizio Cecconi, Prof, MD at Humanitas Research Hospital IRCCS, Rozzano-Milan. The trial plans to enroll 200 participants.