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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02367755
Recruitment Status : Unknown
Verified March 2016 by Yen-Wen Wu, Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : February 20, 2015
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Yen-Wen Wu, Far Eastern Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Hypothermia Cardiac Arrest Drug: Propofol Drug: Lorazepam Phase 4

Detailed Description:

Cardiac arrest and cardiopulmonary resuscitation (CPR) is a specific model of global ischemia/reperfusion (I/R) injury. Among all organ systems, brain is least tolerable to ischemic insult and I/R injury, which accounts for the usually poor survival and neurological outcomes in these patients even with initial success in resuscitation. Therapeutic hypothermia (TH) has been proven to significantly improve the survival and neurological prognoses in patients resuscitated from cardiac arrest. It has been recommended as a standard therapy in the post-resuscitation care since 2002. In the past few years, NTUH and FEMH have been actively promoted the application of TH in the post-resuscitation care, and both have achieved important progress. Based on these, the investigators seek to further improve the survival and neurological outcomes in this group of patients. Among the therapies with potential additive or synergistic protective mechanisms, propofol has been extensively studied, and shown to exhibit great potentials in mitigating ischemia-reperfusion injury via the antioxidative, anti-inflammatory and neuroprotective mechanisms. As sedatives are basic requirement during TH according to technical and ethical concerns, the combination of propofol and TH is not only justified but highly anticipated. The investigators therefore seek to investigate the potentials of propofol in further improving the survival and neurological prognoses in this era of therapeutic hypothermia.

Methods: This .is a prospective, single-blinded randomized clinical trial. The inclusion criteria include: (1) non-traumatic cardiac arrest (2) no regain of consciousness after return of spontaneous circulation (ROSC) (3) age >=20 years old and <= 90 years old. The exclusion criteria include (1) age < 20 y/o or > 90 y/o (2) pregnancy (3) traumatic cardiac arrest (4) fail to achieve ROSC (5) conscious recovery after ROSC (6) contraindications for TH, such as massive bleeding, infections, etc (7) terminal diseases (8) conscious disturbance before cardiac arrest (9) fail to obtain informed consent (10) families refuse to undergo clinical trial. The study will be divided to two groups: (1) Lorazepam group: lorazepam infusion at a rate of 0.5 mg/kg/hr during TH. (2) Propofol group: propofol infusion at a rate of 3 mg/kg/hr during TH. The primary endpoints will be (1) survival (2) neurological outcomes as indicated by cerebral performance category (CPC) scale. The secondary endpoints include (1) 99mTc ECD scan (perfusion and viability), (2) clinical and EEG evidences of seizure. The blood pressure and heart rate will continuously monitored during TH and propofol/lorazepam infusion.

Expected Results: (1) Test if propofol further improves the survival and neurological outcomes in post-CPR patients undergoing TH (2) Test if propofol further improves cerebral perfusion and neuron viability in post-CPR patients undergoing TH (3) Test if propofol reduces the incidence and severity of seizures post-CPR, (4) Test if propofol significantly influence hemodynamics when combined with TH Clinical Implications: Propofol is a clinically available sedative agent. If this trial demonstrates that propofol further improves the survival and neurological outcomes in post-resuscitation patients undergoing TH, it would become an important evidence justifying implementation in clinical practice

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combining Propofol With Therapeutic Hypothermia for Improving Survival and Neurological Prognoses in Patients Resuscitated From Cardiac Arrest
Study Start Date : August 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propofol
propofol infusion at a rate of 3 mg/kg/hr during TH.
Drug: Propofol
Propofol use during therapeutic hypothermia
Other Name: P

Active Comparator: Lorazepam
lorazepam infusion at a rate of 0.5 mg/kg/hr during TH.
Drug: Lorazepam
Lorazepam use during therapeutic hypothermia
Other Name: L




Primary Outcome Measures :
  1. Neurologic statue at discharge [ Time Frame: at dicharge ]
    Glasgow score, cerebral performance category scale


Secondary Outcome Measures :
  1. 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 [ Time Frame: day 5-14 post-resuscitation ]
    Regional Scores of Tc-99m ECD Brain SPECT

  2. From ROSC to recovery of consciousness [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Recovery of consciousness: being able to follow orders. participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

  3. Survival to discharge [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

  1. age < 20 y/o or > 90 y/o
  2. pregnancy
  3. traumatic cardiac arrest
  4. fail to achieve ROSC
  5. conscious recovery after ROSC
  6. contraindications for TH, such as massive bleeding, infections, etc
  7. terminal diseases
  8. conscious disturbance before cardiac arrest
  9. fail to obtain informed consent
  10. families refuse to undergo clinical trial
  11. allergy to propofol or lorazepam.

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): NCT02367755


Contacts
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Contact: Yen-Wen Wu, MD, PhD 886-2-8966-7000 ext 1090 wuyw0502@gmail.com

Locations
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Taiwan
Far Eastern Memorial Hospital Recruiting
New Taipei City, Taiwan, 220
Contact: Yen-Wen Wu, MD, PhD    886-2-8966-7000 ext 1090    wuyw0502@gmail.com   
Principal Investigator: Yen-Wen Wu, MD, PhD         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
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Principal Investigator: Yen-Wen Wu, MD, PhD Far Eastern Memorial Hospital

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Responsible Party: Yen-Wen Wu, Chief of Cardiology Division of Cardiovascular Medical Center and Department of Nuclear Medicine, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02367755    
Other Study ID Numbers: 102060-F_102-FTN12
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not share data
Keywords provided by Yen-Wen Wu, Far Eastern Memorial Hospital:
cardiopulmonary resuscitation
cardiac arrest
therapeutic hypothermia
propofol
lorazepam
cerebral perfusion
electroencephalography
Additional relevant MeSH terms:
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Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Lorazepam
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action