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

March 16, 2021 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
0, 24, and 72 hours
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
0, 24, and 72 hours
The comparison of the number of patients with survival discharge between the 36-TH and 33-TH groups
Time Frame: 6 months
6 months
The comparison of the 6-month cerebral performance scale (CPC) between the 36-TH and 33-TH groups
Time Frame: 6 months
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
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Bard Ltd

Investigators

  • Principal Investigator: Gil Joon Suh, MD, PhD, Seoul National Univerisity College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

July 1, 2020

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (ESTIMATE)

September 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH0620160330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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