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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Mean change in neuron-specific enolase (NSE) [Срок оценки: 72 hours post ROSC]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

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• Limitations of care or life support therapy withdrawn within 24 hours of admission

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• National University Heart Centre, Singapore — Singapore

Идентификаторы

NCT: NCT05679739 · NEURO-INTACT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗