Out-Of-Hospital Cardiac Arrest (OHCA)NCT05679739
NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study
A study testing Individualized blood pressure strategy in people with Out-Of-Hospital Cardiac Arrest (OHCA), run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest (OHCA)
- What is being tested?
- Individualized blood pressure strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Aug 2023to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ≥ 80 years old at time of enrolment
- Pregnant patients
- Limitations of care or life support therapy withdrawn within 24 hours of admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Heart Centre, Singapore
Singapore
Shir Lynn Lim, 69082222, shir_lynn_lim@nuhs.edu.sg
Shir Lynn Lim
About this study
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)
- Being tested
- Individualized blood pressure strategy
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized blood pressure strategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Individualized blood pressure strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in neuron-specific enolase (NSE)
The mean change in concentration of NSE from baseline levels to 72 hours post-ROSC.
Measured: 72 hours post ROSC
Secondary outcomes (13)
Peak concentration of myocardial injury biomarker - High-sensitive troponin (hsTNT)
Peak concentration of myocardial injury biomarker, High-sensitive troponin (hsTNT) within 72 hours of ROSC
Measured: Within 72hours of ROSC
Peak concentration of myocardial injury biomarker - N-terminal pro b-type natriuretic peptide (NT-proBNP)
Peak concentration of myocardial injury biomarker, N-terminal pro b-type natriuretic peptide (NT-proBNP) within 72 hours of ROSC
Measured: Within 72hours of ROSC
Peak concentration of renal function - Creatinine
Peak concentration of renal function, Creatinine within 72 hours of ROSC
Measured: Within 72hours of ROSC
Peak concentration of renal injury biomarker - Proenkephalin A 119-159 (penKID)
Peak concentration of renal injury biomarker, Proenkephalin A 119-159 (penKID) within 72 hours of ROSC
Measured: Within 72hours of ROSC
Peak concentration of renal injury biomarker - Biologically active adrenomedullin (bio-ADM)
Peak concentration of renal injury biomarker, Biologically active adrenomedullin (bio-ADM) within 72 hours of ROSC
Measured: Within 72hours of ROSC
Peak concentration of renal injury biomarker - Tissue inhibitor of metalloproteinases 2 (TIMP2)
Peak concentration of renal injury biomarker, Tissue inhibitor of metalloproteinases 2 (TIMP2) within 72 hours of ROSC
Measured: Within 72hours of ROSC
Peak concentration of renal injury biomarker - Insulin Like Growth Factor Binding Protein 7 (IGFBP7)
Peak concentration of renal injury biomarker, Insulin Like Growth Factor Binding Protein 7 (IGFBP7) within 72 hours of ROSC
Measured: Within 72hours of ROSC
Neurological outcome
Neurological outcomes measured by Cerebral Performance Category (CPC) scale on hospital discharge, and at 3, 6 and 12 months post OHCA. The CPC purports to assess domains of functioning after cardiopulmonary resuscitation (CPR) with scores ranging from 1 (good cerebral performance/normal life) to 5 (brain death).
Measured: Through study completion, average of 12 months post OHCA
Physical function
Physical function measured by the change of Duke Activity Status Index (DASI) self-reported questionnaire on hospital discharge, and at 3, 6 and 12 months post OHCA. DASI score is the sum of the questionnaire responses, score of 34 or less means moderate-to-severe complications.
Measured: Through study completion, average of 12 months post OHCA
Neurocognitive outcome - Montreal Cognitive Assessment (MOCA)
Neurocognitive is assessed by Montreal Cognitive Assessment (MOCA, global cognition) on hospital discharge, and at 3, 6 and 12 months post OHCA. Scores on the MOCA from zero to 30, while score of 26 and above is considered normal.
Measured: Through study completion, average of 12 months post OHCA
Neuropsychological outcome - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Neuropsychological deficits is assessed by the modified local version of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) on hospital discharge, and at 3, 6 and 12 months post OHCA. Standard scores of 70 and above will classify as average/mild impairment, scores 55 to 69 as moderate impairment and severe impairment for scores less than 55.
Measured: Through study completion, average of 12 months post OHCA
Neuropsychological outcome- Depression, Anxiety, and Stress Scale (DASS-21)
Depression, Anxiety, and Stress Scale (DASS-21) is used to assess neuropsychological outcome on hospital discharge, and at 3, 6 and 12 months post OHCA.
Measured: Through study completion, average of 12 months post OHCA
Health-related quality of life
Health-related quality of life measured by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire on hospital discharge, and at 3, 6 and 12 months post OHCA. EQ-5D-5L questionnaire consists of 5 dimensions (mobility, self care, usual activities, pain/comfort, anxiety/depression). There are 5 levels in each dimensions. The lowest level means normal which the highest level means extremely severe.
Measured: Through study completion, average of 12 months post OHCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start29 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac Arrest (OHCA)Studies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shir Lynn Lim, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679739
- Sponsor's protocol ID
- NEURO-INTACT
- Status last verified
- Mar 2025
- First submitted
- 30 Oct 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lim SL, Woo KL, Gandhi M, Beqiri E, Smielewski P, Ong MEH, Sharma VK. Neuroprotection via optimizing cerebral blood flow after cardiac arrest (neuro-intact) study - A phase II proof-of-concept study protocol. Resusc Plus. 2026 Jul 24;31:101430. doi: 10.1016/j.resplu.2026.101430. eCollection 2026 Sep.
PubMed 42598563
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study
- ClinicalTrials.gov ID
- NCT05679739
- Acronym / sponsor ID
- NEURO-INTACT
- Conditions
- Out-Of-Hospital Cardiac Arrest (OHCA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized blood pressure strategy | Experimental | Other: Individualized blood pressure strategyHemodynamic optimization performed to an individualized target mean arterial pressure in the first 72 hours post ROSC based on cerebral perfusion assessed serially. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- ≥ 80 years old at time of enrolment
- Pregnant patients
- Limitations of care or life support therapy withdrawn within 24 hours of admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized blood pressure strategyAn 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. | Other | Individualized blood pressure strategy |
Primary outcome
Mean change in neuron-specific enolase (NSE)
Time frame: 72 hours post ROSC
The mean change in concentration of NSE from baseline levels to 72 hours post-ROSC.
13 secondary outcomes
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
Health-related quality of life
Time frame: Through study completion, average of 12 months post OHCA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 42598563Lim SL, Woo KL, Gandhi M, Beqiri E, Smielewski P, Ong MEH, Sharma VK. Neuroprotection via optimizing cerebral blood flow after cardiac arrest (neuro-intact) study - A phase II proof-of-concept study protocol. Resusc Plus. 2026 Jul 24;31:101430. doi: 10.1016/j.resplu.2026.101430. eCollection 2026 Sep.
Related trials for Out-Of-Hospital Cardiac Arrest (OHCA)
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Recruiting
Mean Arterial Pressure After Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-of-hospital Cardiac Arrest (OHCA)
Recruiting
Ventilation Performance and Feedback Simulation Trial
Out-of-hospital Cardiac Arrest (OHCA)
Recruiting
Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?
Cardiac Arrest (CA)
Active, not recruitingObservational study
Frontal EEG in OHCA Feasibility Study
Out-Of-Hospital Cardiac Arrest, BIS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shir Lynn Lim principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized blood pressure strategy in people with Out-Of-Hospital Cardiac Arrest (OHCA), run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shir Lynn Lim (69082222, shir_lynn_lim@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in neuron-specific enolase (NSE) (time frame: 72 hours post ROSC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05679739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.