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Cardiac ArrestNCT06601842

Monitoring and Optimization of Cerebral Perfusion Pressure in Post-cardiac Arrest Patients: a Pilot Study

A study testing ICP monitoring in people with Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this study is to establish the ICP and CPP monitoring process and analyze the results in post-arrest patients, to validate the correlation between direct and non-invasive ICP monitoring indicators, to establish a protocol of management of elevated ICP and insufficient CPP in post-arrest care, to establish… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrest
What is being tested?
ICP monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTaiwan
Study dates
10 Dec 2024to Dec 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • non-traumatic cardiac arrest
  • admitted to ICU
  • GCS: motor <=5
  • severity: TIMECARD score medium-risk group

Who cannot join

  • traumatic cardiac arrest
  • pregnancy
  • intracranial hemorrhage
  • coagulopathy
  • anti-platelet or anti-coagulation use
  • terminal illness
Show all 9Show fewer
  • pre-arrest CPC score >=3
  • GWR < 1.2 on CT or severe hypoxic ischemic encephalopathy
  • CNS infection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei

    Dean-An Ling, MD, +886-02-23123456, speckle0714@gmail.com

    Recruiting

Other trials in Taiwan

About this study

The goal of this study is to establish the ICP and CPP monitoring process and analyze the results in post-arrest patients, to validate the correlation between direct and non-invasive ICP monitoring indicators, to establish a protocol of management of elevated ICP and insufficient CPP in post-arrest care, to establish a protocol for personalizing CPP and MAP optimization, and to analyze its impact on neuroprognosis.

Participants will receive ICP monitoring within 12 hours post-ROSC if meet all inclusion and exclusion criteria.

Read the detailed description

Post-resuscitation care after cardiac arrest is an important emergency and critical care issue. The post-arrest care after the return of spontaneous circulation has also been incorporated into the chain of survival and resuscitation guidelines. After the regain of spontaneous circulation, cardiac arrest patients will face the challenges of post-arrest syndrome, which includes post-anoxic brain injury, myocardial dysfunction, systemic ischemia-reperfusion, and persistent precipitating causes. The hypoxic brain injury will impair the autoregulation of cerebral blood vessels, thereby affecting the adjustment of intracranial pressure (ICP) and causing cerebral edema. High-quality post-arrest care including targeted temperature management, optimization of hemodynamics and respiratory care, control of blood sugar, monitoring and treatment of epilepsy, etc. The goal is to achieve neuroprotective effects and improve patient outcomes.

The modalities that currently have more evidence for neurocritical care and neuroprognosis include electroencephalogram (EEG) monitoring, pupillary light reflex, brain imaging such as computed tomography (CT) and magnetic resonance imaging (MRI), somatosensory evoked potentials (SSEP), and serum biomarkers such as neuron-specific enolase (NSE), etc. Direct ICP monitoring is not routinely used in cardiac arrest patients due to a lack of clinical experience and concurrent use of antiplatelet medications or anticoagulants. The application of ICP monitoring in neurocritical care can be based on the experience of traumatic brain injury. ICP monitoring can facilitate early detection, determination of treatment strategies, and prediction of outcomes. Cerebral perfusion pressure (CPP) can also be obtained by ICP monitoring. Current head injury treatment guidelines recommend maintaining CPP at around 60-70 mmHg. However, there are no current recommendations for CPP standards for post-arrest patients. In recent years, there have been studies on the utilization of the pressure reactivity index to identify the optimized CPP in patients with traumatic brain injury, but not yet applicated in post-arrest patients.

This study aims to establish the ICP and CPP monitoring process and analyze the result in post-arrest patients, to validate the correlation between direct and non-invasive ICP monitoring indicators, to establish a protocol of management of elevated ICP and insufficient CPP in post-arrest care, to establish a protocol for personalizing CPP and MAP optimization, and to analyze its impact on neuroprognosis.

Conditions
Cardiac Arrest
Being tested
ICP monitoring
Keywords
cardiac arrest, post-arrest care, ICP monitor, Cerebral perfusion pressure
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP monitoringDevice

    ICP monitoring

Study groups in NCT06601842
Study groupRoleWhat they receive
ICP monitoringExperimentalICP monitoring
Receives: Device: ICP monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICP difference between different temperature

    Measured: 12 hour, day 1, 3, 7 post-ROSC

Secondary outcomes (1)
  1. Difference between direct and non-invasive ICP monitoring indicators

    Measured: 12 hour, day 1, 3, 7 post-ROSC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start10 Dec 2024
  3. Primary completionAug 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601842
Sponsor's protocol ID
202407092RINE
Status last verified
Sep 2026
First submitted
14 Sep 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wyckoff MH, Greif R, Morley PT, Ng KC, Olasveengen TM, Singletary EM, Soar J, Cheng A, Drennan IR, Liley HG, Scholefield BR, Smyth MA, Welsford M, Zideman DA, Acworth J, Aickin R, Andersen LW, Atkins D, Berry DC, Bhanji F, Bierens J, Borra V, Bottiger BW, Bradley RN, Bray JE, Breckwoldt J, Callaway CW, Carlson JN, Cassan P, Castren M, Chang WT, Charlton NP, Chung SP, Considine J, Costa-Nobre DT, Couper K, Couto TB, Dainty KN, Davis PG, de Almeida MF, de Caen AR, Deakin CD, Djarv T, Donnino MW, Douma MJ, Duff JP, Dunne CL, Eastwood K, El-Naggar W, Fabres JG, Fawke J, Finn J, Foglia EE, Folke F, Gilfoyle E, Goolsby CA, Granfeldt A, Guerguerian AM, Guinsburg R, Hirsch KG, Holmberg MJ, Hosono S, Hsieh MJ, Hsu CH, Ikeyama T, Isayama T, Johnson NJ, Kapadia VS, Kawakami MD, Kim HS, Kleinman M, Kloeck DA, Kudenchuk PJ, Lagina AT, Lauridsen KG, Lavonas EJ, Lee HC, Lin YJ, Lockey AS, Maconochie IK, Madar RJ, Malta Hansen C, Masterson S, Matsuyama T, McKinlay CJD, Meyran D, Morgan P, Morrison LJ, Nadkarni V, Nakwa FL, Nation KJ, Nehme Z, Nemeth M, Neumar RW, Nicholson T, Nikolaou N, Nishiyama C, Norii T, Nuthall GA, O'Neill BJ, Ong YG, Orkin AM, Paiva EF, Parr MJ, Patocka C, Pellegrino JL, Perkins GD, Perlman JM, Rabi Y, Reis AG, Reynolds JC, Ristagno G, Rodriguez-Nunez A, Roehr CC, Rudiger M, Sakamoto T, Sandroni C, Sawyer TL, Schexnayder SM, Schmolzer GM, Schnaubelt S, Semeraro F, Skrifvars MB, Smith CM, Sugiura T, Tijssen JA, Trevisanuto D, Van de Voorde P, Wang TL, Weiner GM, Wyllie JP, Yang CW, Yeung J, Nolan JP, Berg KM; Collaborators. 2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces. Circulation. 2022 Dec 20;146(25):e483-e557. doi: 10.1161/CIR.0000000000001095. Epub 2022 Nov 3.

    PubMed 36325905
  • Kirkegaard H, Taccone FS, Skrifvars M, Soreide E. Postresuscitation Care after Out-of-hospital Cardiac Arrest: Clinical Update and Focus on Targeted Temperature Management. Anesthesiology. 2019 Jul;131(1):186-208. doi: 10.1097/ALN.0000000000002700.

    PubMed 31021845
  • Nolan JP, Soar J, Cariou A, Cronberg T, Moulaert VR, Deakin CD, Bottiger BW, Friberg H, Sunde K, Sandroni C. European Resuscitation Council and European Society of Intensive Care Medicine Guidelines for Post-resuscitation Care 2015: Section 5 of the European Resuscitation Council Guidelines for Resuscitation 2015. Resuscitation. 2015 Oct;95:202-22. doi: 10.1016/j.resuscitation.2015.07.018. No abstract available.

    PubMed 26477702
  • Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23. No abstract available.

    PubMed 18948368
  • Nolan JP, Sandroni C, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Haywood K, Lilja G, Moulaert VRM, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone F, Soar J. European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2021: post-resuscitation care. Intensive Care Med. 2021 Apr;47(4):369-421. doi: 10.1007/s00134-021-06368-4. Epub 2021 Mar 25.

    PubMed 33765189
  • Sandroni C, Skrifvars MB, Taccone FS. Brain monitoring after cardiac arrest. Curr Opin Crit Care. 2023 Apr 1;29(2):68-74. doi: 10.1097/MCC.0000000000001023. Epub 2023 Feb 16.

    PubMed 36762679
  • Gueugniaud PY, Garcia-Darennes F, Gaussorgues P, Bancalari G, Petit P, Robert D. Prognostic significance of early intracranial and cerebral perfusion pressures in post-cardiac arrest anoxic coma. Intensive Care Med. 1991;17(7):392-8. doi: 10.1007/BF01720676.

    PubMed 1774392
  • Sekhon MS, Griesdale DE, Ainslie PN, Gooderham P, Foster D, Czosnyka M, Robba C, Cardim D. Intracranial pressure and compliance in hypoxic ischemic brain injury patients after cardiac arrest. Resuscitation. 2019 Aug;141:96-103. doi: 10.1016/j.resuscitation.2019.05.036. Epub 2019 Jun 8.

    PubMed 31185256
  • Kjaergaard J, Moller JE, Schmidt H, Grand J, Molstrom S, Borregaard B, Veno S, Sarkisian L, Mamaev D, Jensen LO, Nyholm B, Hofsten DE, Josiassen J, Thomsen JH, Thune JJ, Obling LER, Lindholm MG, Frydland M, Meyer MAS, Winther-Jensen M, Beske RP, Frikke-Schmidt R, Wiberg S, Boesgaard S, Madsen SA, Jorgensen VL, Hassager C. Blood-Pressure Targets in Comatose Survivors of Cardiac Arrest. N Engl J Med. 2022 Oct 20;387(16):1456-1466. doi: 10.1056/NEJMoa2208687. Epub 2022 Aug 27.

    PubMed 36027564
  • Tas J, Beqiri E, van Kaam RC, Czosnyka M, Donnelly J, Haeren RH, van der Horst ICC, Hutchinson PJ, van Kuijk SMJ, Liberti AL, Menon DK, Hoedemaekers CWE, Depreitere B, Smielewski P, Meyfroidt G, Ercole A, Aries MJH. Targeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial. J Neurotrauma. 2021 Oct 15;38(20):2790-2800. doi: 10.1089/neu.2021.0197. Epub 2021 Aug 16.

    PubMed 34407385
  • Tsigaras ZA, Weeden M, McNamara R, Jeffcote T, Udy AA; PRECISION-TBI Investigators. The pressure reactivity index as a measure of cerebral autoregulation and its application in traumatic brain injury management. Crit Care Resusc. 2023 Dec 14;25(4):229-236. doi: 10.1016/j.ccrj.2023.10.009. eCollection 2023 Dec.

    PubMed 38234328

Questions about this trial

What is this clinical trial studying?

A study testing ICP monitoring in people with Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.

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 4 inclusion and 9 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 18 Sep 2026. 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 Taiwan. 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 Dean-An Ling, MD (+886-02-23123456, speckle0714@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICP difference between different temperature (time frame: 12 hour, day 1, 3, 7 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 NCT06601842, which also lists 11 linked publications.

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 18 Sep 2026.

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