Heart ArrestNCT02889744
Comparison of Cerebral SctO2 Between 36℃ and 33℃ of TTM After Cardiac Arrest
A study testing Arctic Sun in people with Heart Arrest, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesize that 1. if decrease in SctO2 level is caused by the degree of hypothermia, SctO2 level in the 33-TH may be lower than that in the 36-TH group. 2. if decrease in SctO2 level is not caused by the degree of hypothermia but caused by brain injury, SctO2 level may be associated with only the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Arctic Sun
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Comatose patients successfully resuscitated from cardiac arrest
Who cannot join
- < 18 years old
- Definite non-cardiac cause arrest
- Contraindication to TH Active bleeding, coagulopathy, fatal arrhythmia, severe infectious condition
- Presence of advanced directives to withhold or withdraw life-sustaining treatment
- Expected survival < 72 hours
- Underlying low CPC (≤ 3)
- No informed consent
- Follow-up loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cerebral Tissue Oxygen Saturation (SctO2) Between 36℃ and 33℃ of Targeted Temperature Management (TTM) After Cardiac Arrest
The investigators hypothesize that
- if decrease in SctO2 level is caused by the degree of hypothermia, SctO2 level in the 33-TH may be lower than that in the 36-TH group.
- if decrease in SctO2 level is not caused by the degree of hypothermia but caused by brain injury, SctO2 level may be associated with only the prognosis of cardiac arrest victims regardless of core temperatures.
The primary objective of this study is to compare the 72-hour changes in SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims.
Read the detailed description
- Subject Identification and Screening For each cohort, patients will be identified after acquisition of sustained return of spontaneous circulation (ROSC) (> 30 minutes). If the patients meet inclusion/exclusion criteria, patients will be enrolled in the study. The investigators will obtain written informed consent from all of the patients or their representatives.
- Assignment of Subject Number A unique identification number will be given to study subjects in an attempt to de-identify their information. Subject numbers will be assigned in sequential order. The subject number will consist of four digits. The first two digits will designate the study site. The last two digits will designate the subject by number in sequential order (i.e., subject number 01 01 will be the first subject at site 1; 01 02 will be the second subject at site 1, etc.).
- Study Methods
- Randomization to 36-TH (core body temperature (BT) 36℃) or 33-TH (core BT 33℃) group will be performed by a web based randomization site (http://mrcc.snuh.org).
- Start target temperature management using external cooling device (Arctic Sun) within 1 hour post-ROSC.
- SctO2 monitoring starts within 1 hour post-ROSC and maintain for 72 hours.
- 36-TH (core BT 36℃) or 33-TH (core BT 33℃) for 24 hours
- Rewarming 0.25℃/h in 33-TH group
- Core temperature < 37.5℃ for 72 hours All patients will be treated per the postresuscitation care protocol. Target treatment will include
- Target: central venous pressure (CVP) (8 - 12 mmHg), mean arterial pressure (MAP) (> 65 mmHg), central venous oxygen saturation (ScvO2) (> 70%)
- Seizure control, shivering control as appropriate
- Coronary intervention as soon as possible if needed
- Infection control if indicated
- Other supportive care Monitoring data including
- CVP, MAP, ScvO2, lactate, neuron specific enolase (NSE), end-tidal carbon dioxide (EtCO2), input-output (I/O) balance
- Intermittent electroencephalography (EEG) monitoring (2 times/72 hours)
- Laboratory data including arterial blood gas analysis (ABGA), complete blood count (CBC), liver function test (LFT), electrolyte, blood urea nitrogen/creatinine (BUN/Cr), et al.
- SctO2
- Core (esophageal or bladder) temperature
- Data Collection
Study data will be collected in the following manner:
- All data will be collected on appropriate Case Report Forms.
- Conditions
- Heart Arrest
- Being tested
- Arctic Sun
- Keywords
- Temperature, Hypothermia, Brain, Oxygen, Prognosis
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arctic SunDevice
Also called External cooling device
Targeted temperature management for 24 hours with core temperature 36℃ or 33℃
| Study group | Role | What they receive |
|---|---|---|
| 36-TH | Active comparator | Core temperature 36℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using Arctic Sun. Receives: Device: Arctic Sun |
| 33-TH | Active comparator | Core temperature 33℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using Arctic Sun. Receives: Device: Arctic Sun |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims
Measured: 72 hour
Secondary outcomes (6)
The comparison of the 72-hour changes in SctO2 level between the 36-TH and 33-TH groups
Measured: 0, 24, and 72 hours
The comparison of the severity scores between the 36-TH and 33-TH groups
- APACHE II score
- Sequential Organ Failure Assessment (SOFA) score
Measured: 0, 24, and 72 hours
The comparison of the serum biomarker levels between the 36-TH and 33-TH groups
- Neuron specific enolase
- Cytokines
- Antioxidants
Measured: 0, 24, and 72 hours
The comparison of the number of patients with survival discharge between the 36-TH and 33-TH groups
Measured: 6 months
The comparison of the 6-month cerebral performance scale (CPC) between the 36-TH and 33-TH groups
Measured: 6 months
Complication of therapeutic hypothermia
- Bleeding requiring transfusion
- Fatal arrhythmia requiring intervention
- Electrolyte imbalance: newly developed abnormal values
- Hyper/hypoglycemia
- Sepsis/pneumonia
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2020
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- From the results of previous studies, we assumed that the mean difference in rSO2 at 72 h between the 36℃ or 33℃ groups would be 3% with 4% of standard deviation. By a referral (2015-0207) to the Medical Research Collaborating Center (MRCC) of SNUH/SNUMC, a sample size of at least 58 (29 per group) was calculated with a power of 0.8 and a significance level of 0.05. Considering an unexpected loss of 15%, the study was planned for 66 participants. Randomization was performed by the 4, 6-block randomization method at the MRCC SNUH/SNUMC web-site (http://mrcc.snu.ac.kr).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bard Ltd
- Responsible party
- Sponsor
- Investigators
- Gil Joon Suh, MD, PhD, Principal investigator, Seoul National Univerisity College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889744
- Sponsor's protocol ID
- SNUH0620160330
- Status last verified
- Mar 2021
- First submitted
- 18 Aug 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
PubMed 11856793Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Aneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Kober L, Langorgen J, Lilja G, Moller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33 degrees C versus 36 degrees C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.
PubMed 24237006Buunk G, van der Hoeven JG, Meinders AE. A comparison of near-infrared spectroscopy and jugular bulb oximetry in comatose patients resuscitated from a cardiac arrest. Anaesthesia. 1998 Jan;53(1):13-9. doi: 10.1111/j.1365-2044.1998.00263.x.
PubMed 9505736Suffoletto B, Kristan J, Rittenberger JC, Guyette F, Hostler D, Callaway C. Near-infrared spectroscopy in post-cardiac arrest patients undergoing therapeutic hypothermia. Resuscitation. 2012 Aug;83(8):986-90. doi: 10.1016/j.resuscitation.2012.03.021. Epub 2012 Apr 19.
PubMed 22521725Meex I, Dens J, Jans F, Boer W, Vanhengel K, Vundelinckx G, Heylen R, De Deyne C. Cerebral tissue oxygen saturation during therapeutic hypothermia in post-cardiac arrest patients. Resuscitation. 2013 Jun;84(6):788-93. doi: 10.1016/j.resuscitation.2013.01.003. Epub 2013 Jan 8.
PubMed 23313422
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cerebral Tissue Oxygen Saturation (SctO2) Between 36℃ and 33℃ of Targeted Temperature Management (TTM) After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02889744
- Acronym / sponsor ID
- SNUH0620160330
- Conditions
- Heart Arrest
- Keywords
- Temperature, Hypothermia, Brain, Oxygen, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Bard Ltd
- Study start
- Mar 2016
- Primary completion
- Jul 2020 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- 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.
The investigators hypothesize that
- if decrease in SctO2 level is caused by the degree of hypothermia, SctO2 level in the 33-TH may be lower than that in the 36-TH group.
- if decrease in SctO2 level is not caused by the degree of hypothermia but caused by brain injury, SctO2 level may be associated with only the prognosis of cardiac arrest victims regardless of core temperatures.
The primary objective of this study is to compare the 72-hour changes in SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims.
Detailed description
- Subject Identification and Screening For each cohort, patients will be identified after acquisition of sustained return of spontaneous circulation (ROSC) (> 30 minutes). If the patients meet inclusion/exclusion criteria, patients will be enrolled in the study. The investigators will obtain written informed consent from all of the patients or their representatives.
- Assignment of Subject Number A unique identification number will be given to study subjects in an attempt to de-identify their information. Subject numbers will be assigned in sequential order. The subject number will consist of four digits. The first two digits will designate the study site. The last two digits will designate the subject by number in sequential order (i.e., subject number 01 01 will be the first subject at site 1; 01 02 will be the second subject at site 1, etc.).
- Study Methods
- Randomization to 36-TH (core body temperature (BT) 36℃) or 33-TH (core BT 33℃) group will be performed by a web based randomization site (http://mrcc.snuh.org).
- Start target temperature management using external cooling device (Arctic Sun) within 1 hour post-ROSC.
- SctO2 monitoring starts within 1 hour post-ROSC and maintain for 72 hours.
- 36-TH (core BT 36℃) or 33-TH (core BT 33℃) for 24 hours
- Rewarming 0.25℃/h in 33-TH group
- Core temperature < 37.5℃ for 72 hours All patients will be treated per the postresuscitation care protocol. Target treatment will include
- Target: central venous pressure (CVP) (8 - 12 mmHg), mean arterial pressure (MAP) (> 65 mmHg), central venous oxygen saturation (ScvO2) (> 70%)
- Seizure control, shivering control as appropriate
- Coronary intervention as soon as possible if needed
- Infection control if indicated
- Other supportive care Monitoring data including
- CVP, MAP, ScvO2, lactate, neuron specific enolase (NSE), end-tidal carbon dioxide (EtCO2), input-output (I/O) balance
- Intermittent electroencephalography (EEG) monitoring (2 times/72 hours)
- Laboratory data including arterial blood gas analysis (ABGA), complete blood count (CBC), liver function test (LFT), electrolyte, blood urea nitrogen/creatinine (BUN/Cr), et al.
- SctO2
- Core (esophageal or bladder) temperature
- Data Collection
Study data will be collected in the following manner:
- All data will be collected on appropriate Case Report Forms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- From the results of previous studies, we assumed that the mean difference in rSO2 at 72 h between the 36℃ or 33℃ groups would be 3% with 4% of standard deviation. By a referral (2015-0207) to the Medical Research Collaborating Center (MRCC) of SNUH/SNUMC, a sample size of at least 58 (29 per group) was calculated with a power of 0.8 and a significance level of 0.05. Considering an unexpected loss of 15%, the study was planned for 66 participants. Randomization was performed by the 4, 6-block randomization method at the MRCC SNUH/SNUMC web-site (http://mrcc.snu.ac.kr).
| Arm | Type | Receives |
|---|---|---|
| 36-TH | Active comparator | Device: Arctic SunCore temperature 36℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using Arctic Sun. |
| 33-TH | Active comparator | Device: Arctic SunCore temperature 33℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using Arctic Sun. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Comatose patients successfully resuscitated from cardiac arrest
Key exclusion criteria (8 listed)
- < 18 years old
- Definite non-cardiac cause arrest
- Contraindication to TH Active bleeding, coagulopathy, fatal arrhythmia, severe infectious condition
- Presence of advanced directives to withhold or withdraw life-sustaining treatment
- Expected survival < 72 hours
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 |
|---|---|---|
| Arctic SunAlso: External cooling deviceTargeted temperature management for 24 hours with core temperature 36℃ or 33℃ | Device | 33-TH, 36-TH |
Primary outcome
The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims
Time frame: 72 hour
6 secondary outcomes
The comparison of the 72-hour changes in SctO2 level between the 36-TH and 33-TH groups
Time frame: 0, 24, and 72 hours
The comparison of the severity scores between the 36-TH and 33-TH groups
Time frame: 0, 24, and 72 hours
The comparison of the serum biomarker levels between the 36-TH and 33-TH groups
Time frame: 0, 24, and 72 hours
The comparison of the number of patients with survival discharge between the 36-TH and 33-TH groups
Time frame: 6 months
The comparison of the 6-month cerebral performance scale (CPC) between the 36-TH and 33-TH groups
Time frame: 6 months
Complication of therapeutic hypothermia
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 11856793Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
- Background: PubMed 24237006Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Aneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Kober L, Langorgen J, Lilja G, Moller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33 degrees C versus 36 degrees C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.
- Results publication: PubMed 9505736Buunk G, van der Hoeven JG, Meinders AE. A comparison of near-infrared spectroscopy and jugular bulb oximetry in comatose patients resuscitated from a cardiac arrest. Anaesthesia. 1998 Jan;53(1):13-9. doi: 10.1111/j.1365-2044.1998.00263.x.
- Results publication: PubMed 22521725Suffoletto B, Kristan J, Rittenberger JC, Guyette F, Hostler D, Callaway C. Near-infrared spectroscopy in post-cardiac arrest patients undergoing therapeutic hypothermia. Resuscitation. 2012 Aug;83(8):986-90. doi: 10.1016/j.resuscitation.2012.03.021. Epub 2012 Apr 19.
- Results publication: PubMed 23313422Meex I, Dens J, Jans F, Boer W, Vanhengel K, Vundelinckx G, Heylen R, De Deyne C. Cerebral tissue oxygen saturation during therapeutic hypothermia in post-cardiac arrest patients. Resuscitation. 2013 Jun;84(6):788-93. doi: 10.1016/j.resuscitation.2013.01.003. Epub 2013 Jan 8.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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. This study is not recruiting at the moment.
Gil Joon Suh, MD, PhD principal investigator
Seoul National Univerisity College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arctic Sun in people with Heart Arrest, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims (time frame: 72 hour). 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 NCT02889744, which also lists 5 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 Mar 2021.