Therapeutic Hypothermia With Propofol in Survival and Neurological Prognoses After Cardiac Arrest
Information source: Far Eastern Memorial Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypothermia; Cardiac Arrest
Intervention: Propofol (Drug); Lorazepam (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Far Eastern Memorial Hospital Official(s) and/or principal investigator(s): Yen-Wen Wu, MD, PhD, Principal Investigator, Affiliation: Far Eastern Memorial Hospital
Overall contact: Yen-Wen Wu, MD, PhD, Phone: 886-2-8966-7000, Ext: 1090, Email: wuyw0502@gmail.com
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.
Clinical Details
Official title: Combining Propofol With Therapeutic Hypothermia for Improving Survival and Neurological Prognoses in Patients Resuscitated From Cardiac Arrest
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Neurologic statue at discharge
Secondary outcome: 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 mFrom ROSC to recovery of consciousness Survival to discharge
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
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Yen-Wen Wu, MD, PhD, Phone: 886-2-8966-7000, Ext: 1090, Email: wuyw0502@gmail.com
Far Eastern Memorial Hospital, New Taipei City 220, Taiwan; Recruiting Yen-Wen Wu, MD, PhD, Phone: 886-2-8966-7000, Ext: 1090, Email: wuyw0502@gmail.com Yen-Wen Wu, MD, PhD, Principal Investigator
Additional Information
Starting date: August 2013
Last updated: February 13, 2015
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