Comparison of Cerebral SctO2 Between 36℃ and 33℃ of TTM After Cardiac Arrest

NCT02889744 | Unknown DMC

• 1 other identifier: SNUH0620160330
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that

1. 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. 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 prognosis of cardiac arrest victims regardless of core temperatures.

Conditions

Heart Arrest

Keywords

Temperature; Hypothermia; Brain; Oxygen; Prognosis

Outcome Measures

Primary Outcomes (1)

• The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims

  72 hour

Secondary Outcomes (6)

• 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

  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

Study Arms (2)

36-TH

ACTIVE COMPARATOR

Core temperature 36℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using Arctic Sun.

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.

Device: Arctic Sun

Interventions

Arctic Sun DEVICE

Targeted temperature management for 24 hours with core temperature 36℃ or 33℃

Also known as: External cooling device

33-TH; 36-TH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Comatose patients successfully resuscitated from cardiac arrest

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Bard Ltd: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (5)

• 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.

  PMID: 11856793 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.

  PMID: 24237006 BACKGROUND

• 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.

  PMID: 9505736 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.

  PMID: 22521725 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.

  PMID: 23313422 RESULT

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gil Joon Suh, MD, PhD

  Seoul National Univerisity College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary and secondary outcomes were assessed by an investigator blinded to this study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: September 7, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

KR (1)