Neuroprotection via optimizing cerebral blood flow after cardiac arrest (neuro-intact) study - A phase II proof-of-concept study protocol.
Shir Lynn Lim, Kai Lee Woo, Mihir Gandhi...
https://pubmed.ncbi.nlm.nih.gov/42598563/Actively Recruiting
Led by National University Hospital, Singapore · Updated on 2025-05-16
49
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating an individualized blood pressure strategy that targets cerebral blood flow after out-of-hospital cardiac arrest OHCA. This approach is compared with standard care to see if it reduces brain injury, measured by changes in neuron-specific enolase, a brain injury biomarker. The study is a proof of concept conducted at a single center and aims to test if personalized blood pressure management improves brain protection after cardiac arrest. The study involves a treatment where blood pressure is carefully adjusted to an individualized target mean arterial pressure during the first 72 hours after return of spontaneous circulation ROSC. This target is determined using brain monitoring software that analyzes data from transcranial Doppler ultrasound and near-infrared spectroscopy, with assessments at admission and at 12, 24, and 48 hours post-ROSC. The intervention group receives this personalized blood pressure management strategy. Participants will be monitored for brain injury using neuron-specific enolase levels at 72 hours post-ROSC as the primary outcome. Secondary outcomes include measurements of heart and kidney injury biomarkers within 72 hours, as well as neurological, physical, cognitive, psychological, and quality of life assessments up to about 12 months after OHCA. The study involves close monitoring and follow-up to evaluate the effects of the intervention over time.
CONDITIONS
NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study
S
Shir Lynn Lim
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National University Hospital, Singapore
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 72 hours post ROSC
Participants receive an individualized blood pressure strategy targeting cerebral blood flow for up to 72 hours after return of spontaneous circulation (ROSC), guided by near-infrared spectroscopy and transcranial Doppler ultrasound.
Assessments on admission, and at 12, 24, and 48 hours post ROSC
Duration - Approximately 12 months post OHCA
Participants are monitored for neurological, physical, neurocognitive, neuropsychological outcomes, and health-related quality of life through study completion, averaging 12 months post out-of-hospital cardiac arrest (OHCA).
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Shir Lynn Lim, Kai Lee Woo, Mihir Gandhi...
https://pubmed.ncbi.nlm.nih.gov/42598563/National University Hospital, Singapore
Lead Sponsor