HypothermiaPhase 4NCT02367755
Therapeutic Hypothermia With Propofol in Survival and Neurological Prognoses After Cardiac Arrest
A Phase 4 study testing Propofol and Lorazepam in people with Hypothermia and Cardiac Arrest, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypothermia, Cardiac Arrest
- What is being tested?
- Propofol and Lorazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-traumatic cardiac arrest
- no regain of consciousness after return of spontaneous circulation (ROSC)
- age >=20 years old and <= 90 years old.
Who cannot join
- 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
Show all 11Show fewer
- terminal diseases
- conscious disturbance before cardiac arrest
- fail to obtain informed consent
- families refuse to undergo clinical trial
- allergy to propofol or lorazepam.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Yen-Wen Wu, MD, PhD, 886-2-8966-7000 ext. 1090, wuyw0502@gmail.com
Yen-Wen Wu, MD, PhD
About this study
Official title: Combining Propofol With Therapeutic Hypothermia for Improving Survival and Neurological Prognoses in Patients Resuscitated From Cardiac Arrest
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.
Read the 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
- Conditions
- Hypothermia, Cardiac Arrest
- Being tested
- Propofol, Lorazepam
- Keywords
- cardiopulmonary resuscitation, cardiac arrest, therapeutic hypothermia, propofol, lorazepam, cerebral perfusion, electroencephalography
- Medical subject headings
- Hypothermia, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called P
Propofol use during therapeutic hypothermia
LorazepamDrug
Also called L
Lorazepam use during therapeutic hypothermia
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | propofol infusion at a rate of 3 mg/kg/hr during TH. Receives: Drug: Propofol |
| Lorazepam | Active comparator | lorazepam infusion at a rate of 0.5 mg/kg/hr during TH. Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic statue at discharge
Glasgow score, cerebral performance category scale
Measured: 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
Regional Scores of Tc-99m ECD Brain SPECT
Measured: day 5-14 post-resuscitation
From ROSC to recovery of consciousness
Recovery of consciousness: being able to follow orders. participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Survival to discharge
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startAug 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Wen Wu, Far Eastern Memorial Hospital
- Investigators
- Yen-Wen Wu, MD, PhD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367755
- Sponsor's protocol ID
- 102060-F_102-FTN12
- Status last verified
- Mar 2016
- First submitted
- 2 Feb 2015
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not share data
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Propofol With Therapeutic Hypothermia for Improving Survival and Neurological Prognoses in Patients Resuscitated From Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02367755
- Acronym / sponsor ID
- 102060-F_102-FTN12
- Conditions
- Hypothermia, Cardiac Arrest
- Keywords
- cardiopulmonary resuscitation, cardiac arrest, therapeutic hypothermia, propofol, lorazepam, cerebral perfusion, electroencephalography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Propofolpropofol infusion at a rate of 3 mg/kg/hr during TH. |
| Lorazepam | Active comparator | Drug: Lorazepamlorazepam infusion at a rate of 0.5 mg/kg/hr during TH. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non-traumatic cardiac arrest
- no regain of consciousness after return of spontaneous circulation (ROSC)
- age >=20 years old and <= 90 years old.
Key exclusion criteria (11 listed)
- age < 20 y/o or > 90 y/o
- pregnancy
- traumatic cardiac arrest
- fail to achieve ROSC
- conscious recovery after ROSC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: PPropofol use during therapeutic hypothermia | Drug | Propofol |
| LorazepamAlso: LLorazepam use during therapeutic hypothermia | Drug | Lorazepam |
Primary outcome
Neurologic statue at discharge
Time frame: at dicharge
Glasgow score, cerebral performance category scale
3 secondary outcomes
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
From ROSC to recovery of consciousness
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Individual participant dataSharing planned: No. Not share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Wen Wu, MD, PhD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Lorazepam in people with Hypothermia and Cardiac Arrest, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen-Wen Wu, MD, PhD (886-2-8966-7000 ext. 1090, wuyw0502@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic statue at discharge (time frame: at dicharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.