Therapeutic Hypothermia With Propofol in Survival and Neurological Prognoses After Cardiac Arrest

NCT02367755 | Unknown Phase 4

• 1 other identifier: 102060-F_102-FTN12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic hypothermia has been proven to significantly improve the survival and neurological prognoses in patients resuscitated from cardiac arrest. Propofol has been reported to exhibit potentials in mitigating ischemia-reperfusion injury via the antioxidative, anti-inflammatory and neuroprotective mechanisms. This study is to investigate the potentials of propofol in further improving the survival and neurological prognoses in this era of therapeutic hypothermia.

Conditions

Hypothermia; Cardiac Arrest

Keywords

cardiopulmonary resuscitation; cardiac arrest; therapeutic hypothermia; propofol; lorazepam; cerebral perfusion; electroencephalography

Outcome Measures

Primary Outcomes (1)

• Neurologic statue at discharge

  Glasgow score, cerebral performance category scale

  at dicharge

Secondary Outcomes (3)

• Brain SPECT The standard 99mTc-ethylene L-cysteinate dimer [ECD] will be done on day 5-14 post-resuscitation. The perfusion will be assessed, and the viability of the cerebral tissue will be interpreted using SPECT, by 2 experienced nuclear m

  day 5-14 post-resuscitation

• From ROSC to recovery of consciousness

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• Survival to discharge

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

Propofol

EXPERIMENTAL

propofol infusion at a rate of 3 mg/kg/hr during TH.

Drug: Propofol

Lorazepam

ACTIVE COMPARATOR

lorazepam infusion at a rate of 0.5 mg/kg/hr during TH.

Drug: Lorazepam

Interventions

Propofol DRUG

Propofol use during therapeutic hypothermia

Also known as: P

Propofol

Lorazepam DRUG

Lorazepam use during therapeutic hypothermia

Also known as: L

Lorazepam

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-traumatic cardiac arrest
• no regain of consciousness after return of spontaneous circulation (ROSC)
• age \>=20 years old and \<= 90 years old.

You may not qualify if:

• age \< 20 y/o or \> 90 y/o
• pregnancy
• traumatic cardiac arrest
• fail to achieve ROSC
• conscious recovery after ROSC
• contraindications for TH, such as massive bleeding, infections, etc
• terminal diseases
• conscious disturbance before cardiac arrest
• fail to obtain informed consent
• families refuse to undergo clinical trial
• allergy to propofol or lorazepam.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Hypothermia; Heart Arrest

Interventions

Propofol; Lorazepam

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yen-Wen Wu, MD, PhD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Wen Wu, MD, PhD

CONTACT

886-2-8966-7000; wuyw0502@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiology Division of Cardiovascular Medical Center and Department of Nuclear Medicine

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 20, 2015
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)