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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:

  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

      Sponsor: Seoul National University Hospital

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

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • 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 ]
      • 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
      • 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
      • The comparison of the number of patients with survival discharge between the 36-TH and 33-TH groups [ Time Frame: 6 months ]
      • The comparison of the 6-month cerebral performance scale (CPC) between the 36-TH and 33-TH groups [ Time Frame: 6 months ]
      • 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


      Original Secondary Outcome: Same as current

      Information By: Seoul National University Hospital

      Dates:
      Date Received: August 18, 2016
      Date Started: March 2016
      Date Completion: September 2018
      Last Updated: August 30, 2016
      Last Verified: March 2016