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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
An 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.
National University Heart Centre, Singapore
Singapore, Singapore
RECRUITINGMean 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 ROSC
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 ROSC
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 ROSC
Peak concentration of renal function - Creatinine
Peak concentration of renal function, Creatinine within 72 hours of ROSC
Time frame: Within 72hours of ROSC
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 ROSC
Peak concentration of renal injury biomarker - Biologically active adrenomedullin (bio-ADM)
Peak concentration of renal injury biomarker, Biologically active adrenomedullin (bio-ADM) within 72 hours of ROSC
Time frame: Within 72hours of ROSC
Peak concentration of renal injury biomarker - Tissue inhibitor of metalloproteinases 2 (TIMP2)
Peak concentration of renal injury biomarker, Tissue inhibitor of metalloproteinases 2 (TIMP2) within 72 hours of ROSC
Time frame: Within 72hours of ROSC
Peak concentration of renal injury biomarker - Insulin Like Growth Factor Binding Protein 7 (IGFBP7)
Peak concentration of renal injury biomarker, Insulin Like Growth Factor Binding Protein 7 (IGFBP7) within 72 hours of ROSC
Time frame: Within 72hours of ROSC
Neurological outcome
Neurological outcomes measured by Cerebral Performance Category (CPC) scale on hospital discharge, and at 3, 6 and 12 months post OHCA. The CPC purports to assess domains of functioning after cardiopulmonary resuscitation (CPR) with scores ranging from 1 (good cerebral performance/normal life) to 5 (brain death).
Time frame: Through study completion, average of 12 months post OHCA
Physical function
Physical function measured by the change of Duke Activity Status Index (DASI) self-reported questionnaire on hospital discharge, and at 3, 6 and 12 months post OHCA. DASI score is the sum of the questionnaire responses, score of 34 or less means moderate-to-severe complications.
Time frame: Through study completion, average of 12 months post OHCA
Neurocognitive outcome - Montreal Cognitive Assessment (MOCA)
Neurocognitive is assessed by Montreal Cognitive Assessment (MOCA, global cognition) on hospital discharge, and at 3, 6 and 12 months post OHCA. Scores on the MOCA from zero to 30, while score of 26 and above is considered normal.
Time frame: Through study completion, average of 12 months post OHCA
Neuropsychological outcome - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Neuropsychological deficits is assessed by the modified local version of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) on hospital discharge, and at 3, 6 and 12 months post OHCA. Standard scores of 70 and above will classify as average/mild impairment, scores 55 to 69 as moderate impairment and severe impairment for scores less than 55.
Time frame: Through study completion, average of 12 months post OHCA
Neuropsychological outcome- Depression, Anxiety, and Stress Scale (DASS-21)
Depression, Anxiety, and Stress Scale (DASS-21) is used to assess neuropsychological outcome on hospital discharge, and at 3, 6 and 12 months post OHCA.
Time frame: Through study completion, average of 12 months post OHCA
Health-related quality of life
Health-related quality of life measured by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire on hospital discharge, and at 3, 6 and 12 months post OHCA. EQ-5D-5L questionnaire consists of 5 dimensions (mobility, self care, usual activities, pain/comfort, anxiety/depression). There are 5 levels in each dimensions. The lowest level means normal which the highest level means extremely severe.
Time frame: Through study completion, average of 12 months post OHCA
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