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NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study

NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study

Recruiting
21-79 years
All
Phase N/A

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Overview

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, compared with standard-of-care, 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, the investigators will randomly assign 90 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 (intervention), versus achieving a standard level of systemic blood pressure (standard-of-care). This is done in a 2:1 allocation (60 to intervention, 30 to standard-of-care), in the first 72 hours after return of spontaneous circulation (ROSC).

Eligibility

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 Limitations of care or life support therapy withdrawn within 24 hours of admission

Study details
    Out-Of-Hospital Cardiac Arrest (OHCA)

NCT05679739

National University Hospital, Singapore

16 April 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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