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AzTrials

Cardiac ArrestTDMCO-ECPRNCT06711016

Target-directed Management of Cerebral Oxygenation in Patients After Receiving ECPR

A study testing if rSO2 < 58%, if rSO2 58%-68% and rSO2>68% in people with Cardiac Arrest, run by Qilu Hospital of Shandong University at 2 sites in China.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

Neurological injury remains an important cause of morbidity and mortality in patients with ECPR. At present, the results of three prospective randomized controlled studies on ECPR are inconsistent, and it is inconclusive whether ECPR can improve the neurological outcomes of patients with refractory cardiac arrest. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cardiac Arrest
What is being tested?
if rSO2 < 58%, if rSO2 58%-68% and rSO2>68%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
654 participants
Where
2 sitesChina
Study dates
22 Apr 2025to 30 Jul 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years old
  • Witnessed in-hospital or out-of-hospital cardiac arrest
  • Patients who did not achieve return of spontaneous circulation (ROSC) after 15 minutes of conventional cardiopulmonary resuscitation (CPR), or whose ROSC cannot be maintained, and who received ECPR
  • Time from cardiac arrest to initiation of CPR < 10 minutes
  • The cause of cardiac arrest is expected to be reversible (e.g., hypothermia, acute myocardial infarction/myocardial ischemia, malignant arrhythmia, pulmonary embolism, electrolyte abnormalities, hypoxia, anaphylactic shock, hemorrhage/hypovolemia, drug poisoning, electric shock, etc.)

Who cannot join

  • Aortic dissection
  • Participants with active gastrointestinal bleeding or other conditions with contraindications to anticoagulation
  • Pregnancy
  • Severe trauma
  • Cerebral Performance Category (CPC) score > 2 before cardiac arrest, or acute cerebrovascular disease (e.g., suspected or confirmed acute stroke, subarachnoid hemorrhage, etc.)
  • Terminal diseases, such as malignant tumors, end-stage liver and kidney diseases, severe heart failure (NYHA class III or IV), severe COPD (GOLD class III or IV), etc.
  • Transfer time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) > 90 minutes
  • Previous history of bilateral femoral artery bypass grafting or artificial vascular replacement, unsuitable for ECMO catheterization

Trial locations and contacts

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

Xianfei Ji, MD. PhD contact

0086-531-82165072

qlyyjxf@163.com

Feng Xu, MD. PhD contact

86-0531-82165675

xufengsdu@126.com

China2 sites, 2 recruiting

  • Qilu Hospital

    Jinan, Shandong, 250012

    Xianfei Ji, MD, PhD, 0086-531-82165072, qlyyjxf@163.com

    Feng Xu, MD. PhD

    Not yet recruiting

  • Qilu hospital

    Jinan, Shandong, 250012

    Xianfei Ji, Doctor, +86118560087427, qlyyjxf@163.com

    Xianfei Ji, Doctor, qlyyjxf@163.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Target-directed Management of Cerebral Oxygenation in Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation: A Multicenter, Pragmatic, Randomized, Controlled Clinical Trial

Neurological injury remains an important cause of morbidity and mortality in patients with ECPR. At present, the results of three prospective randomized controlled studies on ECPR are inconsistent, and it is inconclusive whether ECPR can improve the neurological outcomes of patients with refractory cardiac arrest. Several study found that extracorporeal membrane oxygenation nonsurvivors can lead toacute brain injury.Further research with a systematic neurologic monitoring is necessary to define the timing of acute brain injury in patients with extracorporeal membrane oxygenation.Moreover, brain injury that occurs during extracorporeal membrane oxygenation therapy is not easy to detect in time because of the use of analgesics, sedatives, and muscle relaxants. Surprisingly, little attention has been paid to the role of cerebral perfusion and oxygenation. Moreover,the features of cerebrovascular pathophysiology and optimal management strategies are still vague.

Therefore multimodal neuromonitoring may be a valuable tool for detecting brain injury in patients with extracorporeal membrane oxygenation and providing early intervention guidance.

Read more

Multimodal neuromonitoring, integrating tools such as near-infrared spectroscopy (NIRS), transcranial Doppler, and continuous electroencephalography, may enable early detection of brain injury and guide targeted interventions.

Hypothesis: Multimodal neuromonitoring combined with a standard care management will increase the proportion of patients achieving survival with favorable neurological outcome (Cerebral Performance Category [CPC] 1-2) at 30 days compared with standard care without protocolized neuromonitoring.

Primary Objective: To test whether a multimodal neuromonitoring strategy improves 30-day survival with favorable neurological outcome (CPC 1-2) in adult patients with refractory cardiac arrest treated with ECPR.

Conditions
Cardiac Arrest
Being tested
if rSO2 < 58%, if rSO2 58%-68%, rSO2>68%, Standard monitoring based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions according to the results)., Standard monitoring based on ECPR
Keywords
Multimodality Neuromonitoring, ECPR, Out-of-hospital Caridac arrest, In-Hospital Cardiac Arrest
Medical subject headings
Heart Arrest

What participants receive

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

  • if rSO2 < 58%Other

    Use Vasoactive drugs(MAP 65-95mmHg); Use Cardiotonic agents(CO 3.0-4.5L/min); Increase ECMO blood flow rate(Vm 55-85cm/s); Osmotic dehydration therapy(Na+ 140-150mmol/l;Osmotic pressure 280-320m0sm/(kg·H₂O);ONSD<5.5mm); Antiepileptic therapy(EEG shows no seizures); Optimize sedation and analgesia; Target Temperature Management

  • if rSO2 58%-68%Other

    Optimize ECMO blood flow rate( Vm 55-85cm/s); Osmotic dehydration therapy(Na+ 140-150mmol/l;Osmotic pressure 280-320m0sm/(kg·H₂O);ONSD<5.5mm); Optimize sedation and analgesia; Antiepileptic therapy(EEG shows no seizures); Target Temperature Management

  • rSO2>68%Other

    Antihypertensive therapy(MAP ≥65mmHg); Inhibiting myocardial contractility and controls ventricular rate(CO 2.5-3.0 L/min); Decrease ECMO blood flow rate(Vm 55-85cm/s); Osmotic dehydration therapy(Na+ 140-150mmol/l;Osmotic pressure 280-320m0sm/(kg·H₂O); Antiepileptic therapy(EEG shows no seizures); Optimize sedation and analgesia; Target Temperature Management

  • Standard monitoring based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions according to the results).Other

    Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults (hereinafter referred to as the 2023 AHA Guidelines), including regulating ECMO blood flow, the dose of vasoactive drugs (MAP ≥65 mmHg), mechanical ventilation parameters (SaO₂ 94-98%, PaCO₂ 35-45 mmHg), sedation and analgesia plans. Concurrently, staged target temperature management is implemented, involving maintaining the core temperature 32- 37.5°C within 24 hours, initiating controlled rewarming at a rate of ≤0.1°C/h after 24 hours, and continuing to prevent fever (core temperature ≤37.5°C) within 72 hours.

  • Standard monitoring based on ECPROther

    Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults (hereinafter referred to as the 2023 AHA Guidelines), including regulating ECMO blood flow, the dose of vasoactive drugs (MAP ≥65 mmHg), mechanical ventilation parameters (SaO₂ 94-98%, PaCO₂ 35-45 mmHg), sedation and analgesia plans. Concurrently, staged target temperature management is implemented, involving maintaining the core temperature 32- 37.5°C within 24 hours, initiating controlled rewarming at a rate of ≤0.1°C/h after 24 hours, and continuing to prevent fever (core temperature ≤37.5°C) within 72 hours.

Study groups in NCT06711016
Study groupRoleWhat they receive
controlActive comparatorStandard monitoring (including vital signs monitoring, blood gas analysis, and lactate levels) based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions according to the results). Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults (hereinafter referred to as the 2023 AHA Guidelines), including regulating ECMO blood flow, the dose of vasoactive drugs (MAP ≥65 mmHg), mechanical ventilation parameters (SaO₂ 94-98%, PaCO₂ 35-45 mmHg), sedation and analgesia plans. Concurrently, staged target temperature management is implemented, involving maintaining the core temperature between 32 and 37.5°C within 24 hours, initiating controlled rewarming at a rate of ≤0.1°C/h after 24 hours, and continuing to prevent fever (core temperature ≤37.5°C) within 72 hours.
Receives: Other: Standard monitoring based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions according to the results).
Multimodal monitoring strategyExperimentalExperimental group: In addition to standard treatment in the control group, a multimodal monitoring system of brain function is integrated: continuous rSO2 monitoring with at least once-daily TCD for cerebral blood flow velocity monitoring, ONSD ultrasound measurement, and EEG monitoring. Based on the cerebral oxygenation target-directed management strategies, intervention measures such as the ECMO blood flow, the dose of vasoactive drugs, mechanical ventilation parameters, target temperature management, sedation and analgesia plans, and antiepileptic drugs are dynamically adjusted to ultimately achieve the goal of brain oxygenation target value (rSO2) to 58%-68%.
Receives: Other: if rSO2 < 58%; Other: if rSO2 58%-68%; Other: rSO2>68%; Other: Standard monitoring based on ECPR

What is being measured

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

  1. Favorable neurological outcome (CPC scale 1-2) at 30 days

    Cerebral Performance Category (CPC) score will be performed to evaluate the neurological status. A CPC score of 1 or 2 indicates a favorable neurological status.

    Measured: 30 days

Secondary outcomes (8)

  1. Survival to 30 days and 90 days;

    Does multimodal neurological monitoring Strategy improve the survival rates of 30 days and 90 days after cardiac arrest

    Measured: 30 days and 90 days

  2. Favorable neurological outcome (CPC 1-2) at 90 days;

    Cerebral Performance Category (CPC) score will be performed to evaluate the neurological status. A CPC score of 1 or 2 indicates a favorable neurological status

    Measured: 90 days

  3. Duration of mechanical ventilation

    Is there a difference in the duration of mechanical ventilation between treatment groups

    Measured: 1 year

  4. Length of stay at the ICU

    Is there a difference in length of stay at the ICU between the treatment groups

    Measured: 1 year

  5. Length of stay at the hospital

    Is there a difference in length of stay at the hospital between the treatment groups

    Measured: 1 year

  6. Difference in NSE level between treatment groups

    Is there a difference in nerve damage Markers such as NSE at ROSC 24h, 48h, 72h between the treatment groups

    Measured: 3 days

  7. ECMO-related complication rates such as hemorrhage, infarction, lower limb ischemic necrosis, etc.

    Is there a difference in ECMO-related complication between the treatment groups

    Measured: 1 year

  8. ECMO duration

    Is there a difference in the duration of ECMO between treatment groups

    Measured: 1 year

Timeline

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

  1. First posted2 Dec 2024
  2. Study start22 Apr 2025
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Jul 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
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
The control group: Standard monitoring based on ECPR, along with continuous cerebral oxygenation monitoring (blinded to investigators, with no clinical interventions). Clinical interventions are strictly guided by the 2023 American Heart Association (AHA) Guidelines for Advanced Cardiovascular Life Support in Adults. including regulating ECMO blood flow, the dose of vasoactive drugs , mechanical ventilation parameters, sedation and analgesia plans. The experimental group：For patients with refractory cardiac arrest undergoing ECPR, continuous cerebral oxygenation monitoring was used. Guided by the target-directed management strategies targeting cerebral oxygenation, interventions were dynamically adjusted. These adjustments included modifying ECMO blood flow rates, titrating vasoactive drug dosages, optimizing mechanical ventilation parameters, administering osmotic dehydration therapy, using antiepileptic drugs, and implementing targeted temperature management.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
654 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06711016
Sponsor's protocol ID
KYLL-2025-09-586-1
Acronym
TDMCO-ECPR
Status last verified
Jun 2026
First submitted
4 Nov 2024
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khanduja S, Kim J, Kang JK, Feng CY, Vogelsong MA, Geocadin RG, Whitman G, Cho SM. Hypoxic-Ischemic Brain Injury in ECMO: Pathophysiology, Neuromonitoring, and Therapeutic Opportunities. Cells. 2023 Jun 5;12(11):1546. doi: 10.3390/cells12111546.

    PubMed 37296666

  • Tas J, Eleveld N, Borg M, Bos KDJ, Langermans AP, van Kuijk SMJ, van der Horst ICC, Elting JWJ, Aries MJH. Cerebral Autoregulation Assessment Using the Near Infrared Spectroscopy 'NIRS-Only' High Frequency Methodology in Critically Ill Patients: A Prospective Cross-Sectional Study. Cells. 2022 Jul 21;11(14):2254. doi: 10.3390/cells11142254.

    PubMed 35883697

  • Lim SL, Myint MZ, Woo KL, Chee EYH, Hong CS, Beqiri E, Smielewski P, Ong MEH, Sharma VK. Multi-Modal Assessment of Cerebral Hemodynamics in Resuscitated Out-of-Hospital Cardiac Arrest Patients: A Case-Series. Life (Basel). 2024 Aug 26;14(9):1067. doi: 10.3390/life14091067.

    PubMed 39337852

  • Wei G, Huang G, Zhu C, Jiang W, Hu B: Application of extracorporeal cardiopulmonary resuscitation in emergency refractory cardiac arrest and analysis of prognostic factors. Journal of Practical Medicine 2024, 40(24):3446-3451.

  • Perman SM, Elmer J, Maciel CB, Uzendu A, May T, Mumma BE, Bartos JA, Rodriguez AJ, Kurz MC, Panchal AR, Rittenberger JC; American Heart Association. 2023 American Heart Association Focused Update on Adult Advanced Cardiovascular Life Support: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2024 Jan 30;149(5):e254-e273. doi: 10.1161/CIR.0000000000001194. Epub 2023 Dec 18.

    PubMed 38108133

  • Li X, Mai C: Goal-oriented precision brain resuscitation: current status and prospects. Chinese Journal of Emergency Medicine 2024, 33(1):1-5.

  • Benghanem S, Pruvost-Robieux E, Bouchereau E, Gavaret M, Cariou A. Prognostication after cardiac arrest: how EEG and evoked potentials may improve the challenge. Ann Intensive Care. 2022 Dec 8;12(1):111. doi: 10.1186/s13613-022-01083-9.

    PubMed 36480063

  • Sandroni C, Cronberg T, Hofmeijer J. EEG monitoring after cardiac arrest. Intensive Care Med. 2022 Oct;48(10):1439-1442. doi: 10.1007/s00134-022-06697-y. Epub 2022 Apr 26. No abstract available.

    PubMed 35471582

  • Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.

    PubMed 30019201

  • Calviello LA, Cardim D, Czosnyka M, Preller J, Smielewski P, Siyal A, Damian MS. Feasibility of non-invasive neuromonitoring in general intensive care patients using a multi-parameter transcranial Doppler approach. J Clin Monit Comput. 2022 Dec;36(6):1805-1815. doi: 10.1007/s10877-022-00829-x. Epub 2022 Mar 1.

    PubMed 35230559

  • Rafi S, Tadie JM, Gacouin A, Leurent G, Bedossa M, Le Tulzo Y, Maamar A. Doppler sonography of cerebral blood flow for early prognostication after out-of-hospital cardiac arrest: DOTAC study. Resuscitation. 2019 Aug;141:188-194. doi: 10.1016/j.resuscitation.2019.05.024. Epub 2019 May 27.

    PubMed 31145934

  • Lau VI, Jaidka A, Wiskar K, Packer N, Tang JE, Koenig S, Millington SJ, Arntfield RT. Better With Ultrasound: Transcranial Doppler. Chest. 2020 Jan;157(1):142-150. doi: 10.1016/j.chest.2019.08.2204. Epub 2019 Sep 30.

    PubMed 31580841

  • Green DW, Kunst G. Cerebral oximetry and its role in adult cardiac, non-cardiac surgery and resuscitation from cardiac arrest. Anaesthesia. 2017 Jan;72 Suppl 1:48-57. doi: 10.1111/anae.13740.

    PubMed 28044331

  • Moerman A, De Hert S. Cerebral oximetry: the standard monitor of the future? Curr Opin Anaesthesiol. 2015 Dec;28(6):703-9. doi: 10.1097/ACO.0000000000000256.

    PubMed 26418554

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing if rSO2 < 58%, if rSO2 58%-68% and rSO2>68% in people with Cardiac Arrest, run by Qilu Hospital of Shandong University at 2 sites in China.

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 5 inclusion and 8 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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 Xianfei Ji, MD. PhD (0086-531-82165072, qlyyjxf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Favorable neurological outcome (CPC scale 1-2) at 30 days (time frame: 30 days). 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 NCT06711016, which also lists 25 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 8 Jun 2026.

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