Therapeutic Hypothermia With Propofol in Survival and Neurological Prognoses After Cardiac Arrest
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|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
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia Cardiac Arrest||Drug: Propofol Drug: Lorazepam||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
propofol infusion at a rate of 3 mg/kg/hr during TH.
Propofol use during therapeutic hypothermia
Other Name: P
Active Comparator: Lorazepam
lorazepam infusion at a rate of 0.5 mg/kg/hr during TH.
Lorazepam use during therapeutic hypothermia
Other Name: L
- Neurologic statue at discharge [ Time Frame: at dicharge ]Glasgow score, cerebral performance category scale
- 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
- 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.
- Survival to discharge [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
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
|Contact: Yen-Wen Wu, MD, PhD||886-2-8966-7000 ext firstname.lastname@example.org|
|Far Eastern Memorial Hospital||Recruiting|
|New Taipei City, Taiwan, 220|
|Contact: Yen-Wen Wu, MD, PhD 886-2-8966-7000 ext 1090 email@example.com|
|Principal Investigator: Yen-Wen Wu, MD, PhD|
|Principal Investigator:||Yen-Wen Wu, MD, PhD||Far Eastern Memorial Hospital|