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Recruiting NCT05679739

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

No phase Interventional Out-Of-Hospital Cardiac Arrest (OHCA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individualized blood pressure strategy.
Who it may be relevant to
Registry conditions: Out-Of-Hospital Cardiac Arrest (OHCA). Basic parameters: 21 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 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.

Interventions

  • Other Individualized blood pressure strategy
    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.

Primary outcome measures

  • Mean change in neuron-specific enolase (NSE) [Time frame: 72 hours post ROSC]
Secondary outcome measures (12)
  • Peak concentration of myocardial injury biomarker - High-sensitive troponin (hsTNT) [Time frame: Within 72hours of ROSC]
  • Peak concentration of myocardial injury biomarker - N-terminal pro b-type natriuretic peptide (NT-proBNP) [Time frame: Within 72hours of ROSC]
  • Peak concentration of renal function - Creatinine [Time frame: Within 72hours of ROSC]
  • Peak concentration of renal injury biomarker - Proenkephalin A 119-159 (penKID) [Time frame: Within 72hours of ROSC]
  • Peak concentration of renal injury biomarker - Biologically active adrenomedullin (bio-ADM) [Time frame: Within 72hours of ROSC]
  • Peak concentration of renal injury biomarker - Tissue inhibitor of metalloproteinases 2 (TIMP2) [Time frame: Within 72hours of ROSC]
  • Peak concentration of renal injury biomarker - Insulin Like Growth Factor Binding Protein 7 (IGFBP7) [Time frame: Within 72hours of ROSC]
  • Neurological outcome [Time frame: Through study completion, average of 12 months post OHCA]
  • Physical function [Time frame: Through study completion, average of 12 months post OHCA]
  • Neurocognitive outcome - Montreal Cognitive Assessment (MOCA) [Time frame: Through study completion, average of 12 months post OHCA]
  • Neuropsychological outcome - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time frame: Through study completion, average of 12 months post OHCA]
  • Neuropsychological outcome- Depression, Anxiety, and Stress Scale (DASS-21) [Time frame: Through study completion, average of 12 months post OHCA]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Singapore · 1 center
  • National University Heart Centre, Singapore — Singapore

Identifiers

NCT: NCT05679739 · NEURO-INTACT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗