Clinical trial NCT05679739: NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study
Official title: NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest (OHCA)
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. At least 21 years of age
2. Comatose defined as not being able to obey verbal commands and no verbal response to pain after sustained ROSC.

Exclusion Criteria:

1. ≥ 80 years old at time of enrolment
2. Pregnant patients
3. Limitations of care or life support therapy withdrawn within 24 hours of admission

Primary outcomes:
measure: Mean change in neuron-specific enolase (NSE)
timeFrame: 72 hours post ROSC
Secondary outcomes:
measure: Peak concentration of myocardial injury biomarker - High-sensitive troponin (hsTNT)
timeFrame: Within 72hours of ROSC
measure: Peak concentration of myocardial injury biomarker - N-terminal pro b-type natriuretic peptide (NT-proBNP)
timeFrame: Within 72hours of ROSC
measure: Peak concentration of renal function - Creatinine
timeFrame: Within 72hours of ROSC
measure: Peak concentration of renal injury biomarker - Proenkephalin A 119-159 (penKID)
timeFrame: Within 72hours of ROSC
measure: Peak concentration of renal injury biomarker - Biologically active adrenomedullin (bio-ADM)
timeFrame: Within 72hours of ROSC
measure: Peak concentration of renal injury biomarker - Tissue inhibitor of metalloproteinases 2 (TIMP2)
timeFrame: Within 72hours of ROSC
measure: Peak concentration of renal injury biomarker - Insulin Like Growth Factor Binding Protein 7 (IGFBP7)
timeFrame: Within 72hours of ROSC
measure: Neurological outcome
timeFrame: Through study completion, average of 12 months post OHCA
measure: Physical function
timeFrame: Through study completion, average of 12 months post OHCA
measure: Neurocognitive outcome - Montreal Cognitive Assessment (MOCA)
timeFrame: Through study completion, average of 12 months post OHCA
measure: Neuropsychological outcome - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Through study completion, average of 12 months post OHCA
measure: Neuropsychological outcome- Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Through study completion, average of 12 months post OHCA
measure: Health-related quality of life
timeFrame: Through study completion, average of 12 months post OHCA
Other outcomes:
measure: Exploratory outcome - Digital neurocognitive assessment
timeFrame: Through study completion, average of 12 months post OHCA
Locations:
city: Singapore
country: Singapore
facility: National University Heart Centre, Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Shir Lynn Lim
role: PRINCIPAL_INVESTIGATOR
References: