NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Out-Of-Hospital Cardiac Arrest (OHCA)
- Sponsor
- National University Hospital, Singapore
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Mean change in neuron-specific enolase (NSE)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •≥ 80 years old at time of enrolment
- •Pregnant patients
- •Limitations of care or life support therapy withdrawn within 24 hours of admission
Outcomes
Primary Outcomes
Mean change in neuron-specific enolase (NSE)
Time Frame: 72 hours post ROSC
The mean change in concentration of NSE from baseline levels to 72 hours post-ROSC.
Secondary Outcomes
- Peak concentration of renal injury biomarker - Tissue inhibitor of metalloproteinases 2 (TIMP2)(Within 72hours of ROSC)
- Peak concentration of myocardial injury biomarker - High-sensitive troponin (hsTNT)(Within 72hours of ROSC)
- Peak concentration of renal injury biomarker - Insulin Like Growth Factor Binding Protein 7 (IGFBP7)(Within 72hours of ROSC)
- Physical function(Through study completion, average of 12 months post OHCA)
- Peak concentration of myocardial injury biomarker - N-terminal pro b-type natriuretic peptide (NT-proBNP)(Within 72hours of ROSC)
- Peak concentration of renal injury biomarker - Biologically active adrenomedullin (bio-ADM)(Within 72hours of ROSC)
- Neuropsychological outcome - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Through study completion, average of 12 months post OHCA)
- Health-related quality of life(Through study completion, average of 12 months post OHCA)
- Peak concentration of renal function - Creatinine(Within 72hours of ROSC)
- Neurological outcome(Through study completion, average of 12 months post OHCA)
- Neuropsychological outcome- Depression, Anxiety, and Stress Scale (DASS-21)(Through study completion, average of 12 months post OHCA)
- Peak concentration of renal injury biomarker - Proenkephalin A 119-159 (penKID)(Within 72hours of ROSC)
- Neurocognitive outcome - Montreal Cognitive Assessment (MOCA)(Through study completion, average of 12 months post OHCA)