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

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ClinicalTrials.gov Identifier: NCT02889744
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Bard Ltd
Information provided by (Responsible Party):
Seoul National University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Heart Arrest Device: Arctic Sun Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

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 Name: 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 Name: External cooling device




Primary Outcome Measures :
  1. The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims [ Time Frame: 72 hour ]

Secondary Outcome Measures :
  1. 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 ]
  2. The comparison of the severity scores between the 36-TH and 33-TH groups [ Time Frame: 0, 24, and 72 hours ]
    • APACHE II score
    • Sequential Organ Failure Assessment (SOFA) score

  3. The comparison of the serum biomarker levels between the 36-TH and 33-TH groups [ Time Frame: 0, 24, and 72 hours ]
    • Neuron specific enolase
    • Cytokines
    • Antioxidants

  4. The comparison of the number of patients with survival discharge between the 36-TH and 33-TH groups [ Time Frame: 6 months ]
  5. The comparison of the 6-month cerebral performance scale (CPC) between the 36-TH and 33-TH groups [ Time Frame: 6 months ]
  6. Complication of therapeutic hypothermia [ Time Frame: 72 hours ]
    • Bleeding requiring transfusion
    • Fatal arrhythmia requiring intervention
    • Electrolyte imbalance: newly developed abnormal values
    • Hyper/hypoglycemia
    • Sepsis/pneumonia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889744


Contacts
Contact: Woon Yong Kwon, MD, PhD 82-2-2072-0326 kwy711@hanmail.net
Contact: Yoon Sun Jung, MD 82-10-3260-6113 loctos00@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Woon Yong Kwon, MD, PhD    82-2-2072-0326    kwy711@hanmail.net   
Contact: Yoon Sun Jung, MD    82-2-2262-4808    loctos00@hanmail.net   
Sub-Investigator: Yoon Sun Jung, MD         
Sub-Investigator: Woon Yong Kwon, MD, PhD         
Principal Investigator: Gil Joon Suh, MD, PhD         
Sub-Investigator: Kyung Su Kim, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Bard Ltd
Investigators
Principal Investigator: Gil Joon Suh, MD, PhD Seoul National Univerisity College of Medicine

Publications of Results:
Other Publications:
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02889744     History of Changes
Other Study ID Numbers: SNUH0620160330
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Seoul National University Hospital:
Temperature
Hypothermia
Brain
Oxygen
Prognosis

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases