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| Name | Class |
|---|---|
| Bard Ltd | INDUSTRY |
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The investigators hypothesize that
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.
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
All patients will be treated per the postresuscitation care protocol. Target treatment will include
Monitoring data including
Data Collection
Study data will be collected in the following manner:
• All data will be collected on appropriate Case Report Forms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 36-TH | Active Comparator | Core temperature 36℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Sun | Device | Targeted temperature management for 24 hours with core temperature 36℃ or 33℃ |
|
| Measure | Description | Time Frame |
|---|---|---|
| The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims | 72 hour |
| Measure | Description | Time Frame |
|---|---|---|
| The comparison of the 72-hour changes in SctO2 level between the 36-TH and 33-TH groups | 0, 24, and 72 hours | |
| The comparison of the severity scores between the 36-TH and 33-TH groups |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gil Joon Suh, MD, PhD | Seoul National Univerisity College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11856793 | Background | 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. | |
| 24237006 | Background | Nielsen 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. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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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).
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Primary and secondary outcomes were assessed by an investigator blinded to this study.
| 0, 24, and 72 hours |
| The comparison of the serum biomarker levels between the 36-TH and 33-TH groups |
| 0, 24, and 72 hours |
| The comparison of the number of patients with survival discharge between the 36-TH and 33-TH groups | 6 months |
| The comparison of the 6-month cerebral performance scale (CPC) between the 36-TH and 33-TH groups | 6 months |
| Complication of therapeutic hypothermia |
| 72 hours |
| 9505736 | Result | Buunk 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. |
| 22521725 | Result | Suffoletto 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. |
| 23313422 | Result | Meex 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |