Optimizing cerebral oxygenation in cardiac surgery: A randomized controlled trial examining neurocognitive and perioperative outcomes.
Suzan Uysal, Hung-Mo Lin, Muoi Trinh...
https://pubmed.ncbi.nlm.nih.gov/31056357Actively Recruiting
Phase Not Applicable
Age: 60Years +
All Genders
ID07048002
Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)
Led by Chinese Academy of Medical Sciences, Fuwai Hospital · Updated on 2025-11-24
912
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the NeuroFirst strategy, a combined anesthetic targets bundle aimed at protecting the brain, to see if it can reduce silent brain infarction (SBI) and perioperative neurocognitive disorders (PND) in adults undergoing cardiac surgery. This study compares the NeuroFirst approach with routine care following published guidelines. The trial also assesses the safety of this neuroprotective strategy. Participants are randomly assigned to either the NeuroFirst group or the routine care group. The NeuroFirst bundle focuses on managing mean arterial pressure (MAP), bispectral index (BIS), regional cerebral oxygen saturation (rSO2), and arterial inflow temperature during cardiopulmonary bypass using various treatments and monitoring techniques. The routine care group receives standard management based on institutional guidelines. Throughout the study, participants will undergo brain MRI scans, and assessments using the Confusion Assessment Method and Montreal Cognitive Assessment. Researchers will monitor participants for up to one year after surgery, measuring the incidence of new silent brain infarctions within 7 days, neurocognitive disorders, delirium, strokes, transient ischemic attacks, and major adverse events at multiple time points. Safety and long-term outcomes will also be tracked during follow-up.
CONDITIONS
Brief Title
Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female adult patients aged 60 years or older
- Scheduled for elective cardiovascular surgery with cardiopulmonary bypass
- Provided written informed consent
You will not qualify if you...
- Contraindication to MRI scanning
- Unable to receive interventions to achieve NeuroFirst target bundle
- Unable to complete neurocognitive evaluations due to language, vision, or hearing impairments
- Pregnant or breastfeeding
- Terminal illness with life expectancy under 3 months
- Mental or legal disability
- Currently enrolled in another interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Surgery day and intraoperative period
Participants undergo elective cardiovascular surgery with cardiopulmonary bypass. They are managed either with the NeuroFirst target bundle aimed at specific intraoperative physiological targets or with routine institutional management according to published guidelines.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 1 year postoperatively
Participants are monitored for new brain infarctions, neurocognitive disorders, delirium, stroke, and other major adverse events following surgery.
Visits at 7 days, 30 days, and up to 1 year after surgery
Trial Site Locations
Total: 5 locations
1
Beijing Chaoyang Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
2
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
3
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
4
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100160
Actively Recruiting
5
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430014
Actively Recruiting
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Research Team
J
Jia Shi, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Prolonged concurrent hypotension and low bispectral index ('double low') are associated with mortality, serious complications, and prolonged hospitalization after cardiac surgery.
A Maheshwari, P J McCormick, D I Sessler...
https://pubmed.ncbi.nlm.nih.gov/28974062Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial.
Richard Descamps, Julien Amour, Emmanuel Besnier...
https://pubmed.ncbi.nlm.nih.gov/36934980Silent Brain Infarction, Delirium, and Cognition in Three Invasive Cardiovascular Procedures: a Systematic Review.
Adam Gerstenecker, Amani M Norling, Alexandra Jacob...
https://pubmed.ncbi.nlm.nih.gov/35804216Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery.
M F Newman, J L Kirchner, B Phillips-Bute...
https://pubmed.ncbi.nlm.nih.gov/11172175Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery.
Charles H Brown, Julia Probert, Ryan Healy...
https://pubmed.ncbi.nlm.nih.gov/29771710Targeting neuroinflammation as a preventive and therapeutic approach for perioperative neurocognitive disorders.
Chun Cheng, Hanxi Wan, Peilin Cong...
https://pubmed.ncbi.nlm.nih.gov/36503642Silent Brain Infarcts Following Cardiac Procedures: A Systematic Review and Meta-Analysis.
Ben Indja, Kei Woldendorp, Michael P Vallely...
https://pubmed.ncbi.nlm.nih.gov/31017035Silent brain infarcts and the risk of dementia and cognitive decline.
Sarah E Vermeer, Niels D Prins, Tom den Heijer...
https://pubmed.ncbi.nlm.nih.gov/12660385The epidemiology of silent brain infarction: a systematic review of population-based cohorts.
Jonathon P Fanning, Andrew A Wong, John F Fraser
https://pubmed.ncbi.nlm.nih.gov/25012298