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CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State

Study acronym: CERBERUS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2026 → Dec 2026
See other at-risk trials from Beth Israel Deaconess Medical Center

Record History

  1. Primary completion pushed from Jun 2026 to Dec 2026 Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 3 of 7 entries · Study description expanded, about 32 words · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Study description expanded, about 32 words
    • Publications: details revised at 20 of 21 entries
  2. Primary completion date: Mar 2025 to Jun 2026 Completion date: Sep 2025 to Jul 2027v3 Show 1 more changeShow less
    • Completion date: Sep 2025 to Jul 2027
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2023 to Apr 17, 2024 · Study sites: 0 to 1 · Primary completion date: Sep 2024 to Mar 2025 · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of Dec 2023 to Apr 17, 2024
    • Study sites: 0 to 1
    • Primary completion date: Sep 2024 to Mar 2025
    • Completion date: Nov 2024 to Sep 2025
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question\[s\] it aims to answer are: * Is there a way to tailor the blood pressure to be maintained in such patients during surgery for optimal brain health using non-invasive monitors that check the brains electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood oxygen levels, the cerebral oximetry(CO) monitor? * How much does this optimal blood pressure level vary between patients? Participants will be asked to: * Complete a questionnaire at the time they enroll into the study, as well as a daily questionnaire to help determine their level of thinking and brain health. This questionnaire will be administered by a member of the study team. * They will also have an EEG and CO monitoring sticker placed on their foreheads. This will be connected to a monitor that will collect this data just before, during, and after their surgery. The data collected through these monitors will help us with our study goals.
Trial Details
NCT Number NCT06133842
Lead Sponsor Beth Israel Deaconess Medical Center
Conditions Perioperative/Postoperative Complications, Postoperative Cognitive Dysfunction, Postoperative Delirium, EEG With Periodic Abnormalities, Intraoperative Hypotension, Cerebral Hypoperfusion
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov