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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02889744

Collaborator

Bard Ltd (Industry)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Arrest	Device: Arctic Sun	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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 (Outcomes Assessor)

Masking Description:

Primary and secondary outcomes were assessed by an investigator blinded to this study.

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 36-TH Core temperature 36℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using Arctic Sun.	Device: Arctic Sun Targeted temperature management for 24 hours with core temperature 36℃ or 33℃ Other Names: External cooling device
Active Comparator: 33-TH Core temperature 33℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using Arctic Sun.	Device: Arctic Sun Targeted temperature management for 24 hours with core temperature 36℃ or 33℃ Other Names: External cooling device

Arm

Intervention/Treatment

Active Comparator: 36-TH

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

Device: Arctic Sun

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

Other Names:

External cooling device

Active Comparator: 33-TH

Core temperature 33℃ of targeted temperature management (36-TH) for 24 hours in cardiac arrest victims using Arctic Sun.

Device: Arctic Sun

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

Other Names:

External cooling device

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
APACHE II score Sequential Organ Failure Assessment (SOFA) score
The comparison of the serum biomarker levels between the 36-TH and 33-TH groups [0, 24, and 72 hours]
Neuron specific enolase Cytokines Antioxidants
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]
Bleeding requiring transfusion Fatal arrhythmia requiring intervention Electrolyte imbalance: newly developed abnormal values Hyper/hypoglycemia Sepsis/pneumonia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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