NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-79
SponsorNational University Hospital, Singapore
About this trial
This single-center proof of concept study aims to assess the efficacy of a blood pressure strategy targeting person- and time-specific cerebral blood flow compared with standard-of-care using neuron-specific enolase as a quantitative biomarker of brain injury. Our central hypothesis is that an individualized blood pressure strategy targeting cerebral perfusion will reduce the extent of brain injury as indicated by changes in levels of neuron-specific enolase from baseline at 72 hours. To test this hypothesis, we will recruit 49 patients to an individualized blood pressure management strategy targeting cerebral blood flow, where optimal blood pressure will be serially calculated by the ICM+ brain monitoring software (Cambridge, UK) using inputs from transcranial Doppler ultrasound and near-infrared spectroscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 21 years of age
Comatose defined as not being able to obey verbal commands and no verbal response to pain after sustained ROSC.
Disqualifiers
≥ 80 years old at time of enrolment
Pregnant patients
Limitations of care or life support therapy withdrawn within 24 hours of admission
Trial design
Design model
Single group
Treatments tested in this trial
Individualized blood pressure strategy
Other interventionAn individualized blood pressure strategy targeting cerebral blood flow, serially guided by near-infrared spectroscopy and transcranial Doppler ultrasound. Assessments are performed on admission, and at 12, 24 and 48 hours post-ROSC.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Individualized blood pressure strategyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean change in neuron-specific enolase (NSE)
The mean change in concentration of NSE from baseline levels to 72 hours post-ROSC.
Time frame
72 hours post ROSCSecondary outcomes
1
Peak concentration of myocardial injury biomarker - High-sensitive troponin (hsTNT)
Peak concentration of myocardial injury biomarker, High-sensitive troponin (hsTNT) within 72 hours of ROSC
Time frame
Within 72hours of ROSC2
Peak concentration of myocardial injury biomarker - N-terminal pro b-type natriuretic peptide (NT-proBNP)
Peak concentration of myocardial injury biomarker, N-terminal pro b-type natriuretic peptide (NT-proBNP) within 72 hours of ROSC
Time frame
Within 72hours of ROSC3
Peak concentration of renal function - Creatinine
Peak concentration of renal function, Creatinine within 72 hours of ROSC
Time frame
Within 72hours of ROSC4
Peak concentration of renal injury biomarker - Proenkephalin A 119-159 (penKID)
Peak concentration of renal injury biomarker, Proenkephalin A 119-159 (penKID) within 72 hours of ROSC
Time frame
Within 72hours of ROSCOther outcomes
1
Exploratory outcome - Digital neurocognitive assessment
Neurocognitive is assessed by digital neurocognitive assessment on hospital discharge, and at 3, 6 and 12 months post OHCA.
Time frame
Through study completion, average of 12 months post OHCASponsors and contacts
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Source ClinicalTrials.gov