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

NCT05679739 | Recruiting DMC

• 1 other identifier: NEURO-INTACT
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Out-Of-Hospital Cardiac Arrest (OHCA)

Outcome Measures

Primary Outcomes (1)

• Mean change in neuron-specific enolase (NSE)

  The mean change in concentration of NSE from baseline levels to 72 hours post-ROSC.

  72 hours post ROSC

Secondary Outcomes (13)

• Peak concentration of myocardial injury biomarker - High-sensitive troponin (hsTNT)

  Within 72hours of ROSC

• Peak concentration of myocardial injury biomarker - N-terminal pro b-type natriuretic peptide (NT-proBNP)

  Within 72hours of ROSC

• Peak concentration of renal function - Creatinine

  Within 72hours of ROSC

• Peak concentration of renal injury biomarker - Proenkephalin A 119-159 (penKID)

  Within 72hours of ROSC

• Peak concentration of renal injury biomarker - Biologically active adrenomedullin (bio-ADM)

  Within 72hours of ROSC

Other Outcomes (1)

• Exploratory outcome - Digital neurocognitive assessment

  Through study completion, average of 12 months post OHCA

Study Arms (1)

Individualized blood pressure strategy

EXPERIMENTAL

Hemodynamic optimization performed to an individualized target mean arterial pressure in the first 72 hours post ROSC based on cerebral perfusion assessed serially.

Other: Individualized blood pressure strategy

Interventions

Individualized blood pressure strategy OTHER

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.

Individualized blood pressure strategy

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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• Limitations of care or life support therapy withdrawn within 24 hours of admission

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Heart Centre, Singapore

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Shir Lynn Lim

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shir Lynn Lim

CONTACT

69082222; shir_lynn_lim@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: January 11, 2023
• Study Start: August 29, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-03

Locations

SG (1)