Targeted Temperature Management After In-Hospital Cardiac Arrest

NCT02578823 | Unknown

• 1 other identifier: 2015-1071
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether targeted temperature management at 36.0˚C(TTM-36) in patients who remain unconscious after resuscitation from in-hospital cardiac arrest(IHCA) will reduce death and disability compared with fever control. For this purpose, the current pilot study will be undertaken to establish the feasibility, safety, and surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain unconscious after resuscitation from IHCA. Eligible patients will be randomly assigned in a 2:1 ratio to either TTM-36(n=40) or conventional treatment group(n=20). Randomization will be performed with stratification according to initial rhythm (shockable vs. non-shockable).

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Targeted Temperature Management(TTM); in-hospital cardiac arrest(IHCA); restoration of spontaneous circulation(ROSC); unconsciousness; brain injury

Outcome Measures

Primary Outcomes (1)

• Combination of death and poor neurological function defined as a Cerebral Performance Category (CPC) score 3 to 5 at 180 days

  Efficacy of targeted temperature management at 36.0℃(TTM-36) will be assessed by using Cerebral Performance Category(CPC) score. CPC score is the surrogate outcome for hypoxic-ischemic brain injury.

  day 180

Secondary Outcomes (10)

• The CPC score 3 to 5 at day 7 and at day 30

  day 7, day 30

• The highest levels of serum neuron specific enolase(NSE) during the first 5 days

  up to day 5

• Unfavorable Electroencephalography(EEG) patterns

  day 0, day 4

• Assessment of magnetic resonance imaging(MRI) at day 4

  day 4

• Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180

  day 30, day 180

Other Outcomes (2)

• Safety of the targeted temperature management at 36.0℃(TTM-36)

  up to day 7

• Feasibility

  up to day 180

Study Arms (2)

TTM-36

EXPERIMENTAL

Participants assigned to TTM-36 Arm will be managed by Arcticgel™ and Arctic Sun® to maintain core temperatureTemperature at 36.0℃ for 72 hours. After targeted temperature management(TTM), Fever will be controlled for remaining 7 days by conventional antipyretic treatment. (Treat core temperature ≥ 38.3℃). A total of 40 participants will be enrolled.

Device: Arctic Sun®; Device: Arcticgel™; Procedure: Conventional antipyretic treatment

Conventional treatment

ACTIVE COMPARATOR

Participants who are assigned to this Arm will be treated with conventional antipyretic treatment regarding the occurrence fever for 7 days.(Treat core temperature ≥ 38.3℃). A total of 20 participants will be enrolled.

Procedure: Conventional antipyretic treatment

Interventions

Arctic Sun® DEVICE

Core temperature is maintained to 36℃ for 3 days by using the skin attached pad(Arcticgel™) and targeted temperature management(Arctic Sun®).

Also known as: Temperature Management System Model 5000

TTM-36

Arcticgel™ DEVICE

Also known as: Hydrogel Coated Pad

TTM-36

Conventional antipyretic treatment PROCEDURE

Conventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc.

Conventional treatment; TTM-36

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• In-hospital cardiac arrest requiring chest compression for \> 2 minutes
• Sustained restoration of spontaneous circulation(ROSC) for \> 20 minutes after cardiopulmonary resuscitation(CPR)
• Unresponsive state(lack of meaningful response to verbal commands) for \> 20 minutes after sustained ROSC
• Informed consents from a patient's family member

You may not qualify if:

• Unavailable TTM within 2 hours after ROSC
• CPR duration \> 30 minutes
• Unwitnessed arrest with initial rhythm asystole
• Under or planned for extracorporeal membrane oxygenation(ECMO)
• Initial body temperature \< 33 °C
• Preexisting terminal illness with life expectancy \<6 months
• Pre-admission CPC score of 3-5
• Pre-admission mRS score 4-6
• Unresponsive(stupor or coma) before cardiac arrest
• Suspected or confirmed cause of cardiac arrest is diseases of the central nervous system, such as stroke, brain tumor, or amyotrophic lateral sclerosis
• Any condition in which direct skin surface cooling would be contraindicated, such as large burns, unhealed surgical wounds, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity
• Active massive bleeding
• Major surgery within last 48 hours
• Cardiothoracic surgery within 14 days
• Planned surgery within next 72 hours after ROSC

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Unconsciousness; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sang-Beom Jeon, Dr

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Beom Jeon, Dr

CONTACT

82-2-3010-3440; sbjeonmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: January 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

KR (1)