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

Heart Arrest Clinical Trial

Official title:

Comparison of Cerebral Tissue Oxygen Saturation (SctO2) Between 36℃ and 33℃ of Targeted Temperature Management (TTM) After Cardiac Arrest

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02889744
• Other study ID #: SNUH0620160330
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2021

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

1. 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.

2. 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.).

3. 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

4. Data Collection

Study data will be collected in the following manner:

• All data will be collected on appropriate Case Report Forms.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: March 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Comatose patients successfully resuscitated from cardiac arrest

Exclusion Criteria:

• < 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

Related Conditions & MeSH terms

• Heart Arrest

Intervention

Device:
• Arctic Sun
Targeted temperature management for 24 hours with core temperature 36? or 33?

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bard Ltd

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

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. Erratum in: N Engl J Med 2002 May 30;346(22):1756. — View Citation

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. — View Citation

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, Åneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Køber L, Langørgen J, Lilja G, Møller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33°C versus 36°C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims		72 hour
Secondary	The comparison of the 72-hour changes in SctO2 level between the 36-TH and 33-TH groups		0, 24, and 72 hours
Secondary	The comparison of the severity scores between the 36-TH and 33-TH groups	APACHE II score; Sequential Organ Failure Assessment (SOFA) score	0, 24, and 72 hours
Secondary	The comparison of the serum biomarker levels between the 36-TH and 33-TH groups	Neuron specific enolase; Cytokines; Antioxidants	0, 24, and 72 hours
Secondary	The comparison of the number of patients with survival discharge between the 36-TH and 33-TH groups		6 months
Secondary	The comparison of the 6-month cerebral performance scale (CPC) between the 36-TH and 33-TH groups		6 months
Secondary	Complication of therapeutic hypothermia	Bleeding requiring transfusion; Fatal arrhythmia requiring intervention; Electrolyte imbalance: newly developed abnormal values; Hyper/hypoglycemia; Sepsis/pneumonia	72 hours