Out-of-Hospital Cardiac ArrestEarly Phase 1NCT00965016
Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation.
A Early Phase 1 study testing hypothermia in people with Out-of-Hospital Cardiac Arrest, run by Min-Sheng General Hospital at 1 site in Taiwan.
Trial summary
Background： Cardiopulmonary resuscitation (CPR) with closed-chest cardiac massage has been shown that survival to discharge rate is poor. Attempt to increase success, some aggressive methods such as extracorporeal membrane oxygenation (ECMO) has been used (also known as extracorporeal cardiopulmonary resuscitation… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Dec 2009
- Phase
- Early Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. in cardiac arrest that necessitated external or open-chest cardiac massage and a large amount of epinephrine (>5 mg) during CPR.
- 2. Could not be returned to spontaneous circulation within 10 to 20 min
Who cannot join
- contraindicated to ECMO use
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Min-sheng General Hospital
Taoyuan, 330
Yao, Physician, 886-3-3179599 ext. 2007
About this study
Official title: The Therapeutic Effect of Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation (ECPR).
Background： Cardiopulmonary resuscitation (CPR) with closed-chest cardiac massage has been shown that survival to discharge rate is poor. Attempt to increase success, some aggressive methods such as extracorporeal membrane oxygenation (ECMO) has been used (also known as extracorporeal cardiopulmonary resuscitation, ECPR). Otherwise, anoxic brain injury is another issue after CPR. In recent years, some randomized prospective controlled trials of induced hypothermia (IH) to 33℃ for 12 to 24 hours has been demonstrated to significantly improve outcome in cardiac arrest patients. Because ECMO also could provide hypothermia management, we plan this study to evaluate the cerebroprotective effect of ECPR with induced hypothermia. We will try to analyze risk factors influencing patient survival and weaning from ECPR and the optimal management for this ominous prognosis group.
Method:
Read more
The patients were recruited into the ECPR group only if they:
- in cardiac arrest that necessitated external or open-chest cardiac massage and a large amount of epinephrine (>5 mg) during CPR.
- Could not be returned to spontaneous circulation within 10 to 20 min. After ECPR, the body temperature was started to be cooled down. Within 3 hours, the patients have been well studied to search for potential reason of CPR. If the patients have no heart problem or only intervention needed, they can be grouped into 1. Group 2 is the group, which some further operation must be delivered. Group 3 is the group who cannot afford to receive hypothermia (The physician in charge don't agree the trial.) In ECMO-supported patients, two resulting comparisons were of concern: 1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death. We attempted to identify the risk factors that affected weaning and survival, and we analyzed the effect of ECPR with hypothermia on survival.
Expected result:
We will prove ECPR with hypothermia is a perfect strategy. And within three groups of the patients, ECMO +induced hypothermia will be the most optimal choice.
Read the detailed description
Induced Hypothermia Protocol for comatose patient from CPR Core temperature: 34.9℃ within 30 min, 33.5℃ within 120min and 33℃ for 12-24 Hours
- Decrease temperature in 0.9℃/hour
- CVP monitoring
- the infusions were temporarily stopped if CVP increased > 5 mm Hg over 5 mins.
- Continuous temperature monitoring with a rectal probe or bladder catheter
- One must be vigilant to avoid k+, Ma2+, and P depletion during and immediately after the infusion, particularly given the increased risk of cardiac arrhythmia that occurs with induced hypothermia.
- An evaluation of neurologic status
- IV Dormicum (midazolam 2 to 5 mg或0.125 mg/kg/hr initially) and fentanyl (0.002 mg/kg/hr initially), Pavulon (pancuronium 0.1 mg/kg) every 2 hours for a total of 32 hours.
- ABG values were used to adjust the ventilator to maintain PaO2>100 mm Hg and PaCO2<40 mm Hg.
- MAP: 90 ~ 100 mm Hg
- Lidocaine bolus (1 mg/kg) followed by an infusion (2 mg/min for 24 hours)
- K+> 4.0 mmol/L
- RI infusion < 180 mg/deciliter (10 mmol per liter)
- Antibiotics with β-lactam；Aspirin
- The temperature was maintained at 33℃ for 24 hours from the start of cooling, followed by passive rewarming, which we expected would occur over a period of 8 hours, followed by active rewarming.
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- hypothermia
- Keywords
- Extracorporeal membrane oxygenation，induced hypothermia
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothermiaProcedure or surgery
Also called ECPR
Core temperature --> 34.9℃ within 30 min --> 33.5℃ within 120min --> 33℃for 24 H Decrease temperature in 0.9℃/hour
| Study group | Role | What they receive |
|---|---|---|
| No Hypothermia, No intervention, ECMO | Sham comparator | No hypothermia used during ECPR Receives: Procedure: hypothermia |
| Hypothermia, intervention, ECMO | Active comparator | Hypothermia + intervention Receives: Procedure: hypothermia |
| Hypothermia, no intervention, ECMO | Active comparator | Hypothermia without intervention after ECMO Receives: Procedure: hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death.
Measured: 20091231
Secondary outcomes (1)
Brain injury
Measured: 20091231
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital Cardiac ArrestStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Sheng General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shaojung Li, physician, Principal investigator, Director, department of cardiovascular surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965016
- Sponsor's protocol ID
- MSEIRB0980106
- Status last verified
- Aug 2009
- First submitted
- 23 Aug 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation (ECPR).
- ClinicalTrials.gov ID
- NCT00965016
- Acronym / sponsor ID
- MSEIRB0980106
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Extracorporeal membrane oxygenation，induced hypothermia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Min-Sheng General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 25 Aug 2009 (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.
Background： Cardiopulmonary resuscitation (CPR) with closed-chest cardiac massage has been shown that survival to discharge rate is poor. Attempt to increase success, some aggressive methods such as extracorporeal membrane oxygenation (ECMO) has been used (also known as extracorporeal cardiopulmonary resuscitation, ECPR). Otherwise, anoxic brain injury is another issue after CPR. In recent years, some randomized prospective controlled trials of induced hypothermia (IH) to 33℃ for 12 to 24 hours has been demonstrated to significantly improve outcome in cardiac arrest patients. Because ECMO also could provide hypothermia management, we plan this study to evaluate the cerebroprotective effect of ECPR with induced hypothermia. We will try to analyze risk factors influencing patient survival and weaning from ECPR and the optimal management for this ominous prognosis group.
Method:
The patients were recruited into the ECPR group only if they:
- in cardiac arrest that necessitated external or open-chest cardiac massage and a large amount of epinephrine (>5 mg) during CPR.
- Could not be returned to spontaneous circulation within 10 to 20 min. After ECPR, the body temperature was started to be cooled down. Within 3 hours, the patients have been well studied to search for potential reason of CPR. If the patients have no heart problem or only intervention needed, they can be grouped into 1. Group 2 is the group, which some further operation must be delivered. Group 3 is the group who cannot afford to receive hypothermia (The physician in charge don't agree the trial.) In ECMO-supported patients, two resulting comparisons were of concern: 1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death. We attempted to identify the risk factors that affected weaning and survival, and we analyzed the effect of ECPR with hypothermia on survival.
Expected result:
We will prove ECPR with hypothermia is a perfect strategy. And within three groups of the patients, ECMO +induced hypothermia will be the most optimal choice.
Detailed description
Induced Hypothermia Protocol for comatose patient from CPR Core temperature: 34.9℃ within 30 min, 33.5℃ within 120min and 33℃ for 12-24 Hours
- Decrease temperature in 0.9℃/hour
- CVP monitoring
- the infusions were temporarily stopped if CVP increased > 5 mm Hg over 5 mins.
- Continuous temperature monitoring with a rectal probe or bladder catheter
- One must be vigilant to avoid k+, Ma2+, and P depletion during and immediately after the infusion, particularly given the increased risk of cardiac arrhythmia that occurs with induced hypothermia.
- An evaluation of neurologic status
- IV Dormicum (midazolam 2 to 5 mg或0.125 mg/kg/hr initially) and fentanyl (0.002 mg/kg/hr initially), Pavulon (pancuronium 0.1 mg/kg) every 2 hours for a total of 32 hours.
- ABG values were used to adjust the ventilator to maintain PaO2>100 mm Hg and PaCO2<40 mm Hg.
- MAP: 90 ~ 100 mm Hg
- Lidocaine bolus (1 mg/kg) followed by an infusion (2 mg/min for 24 hours)
- K+> 4.0 mmol/L
- RI infusion < 180 mg/deciliter (10 mmol per liter)
- Antibiotics with β-lactam；Aspirin
- The temperature was maintained at 33℃ for 24 hours from the start of cooling, followed by passive rewarming, which we expected would occur over a period of 8 hours, followed by active rewarming.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Hypothermia, No intervention, ECMO | Sham comparator | Procedure: hypothermiaNo hypothermia used during ECPR |
| Hypothermia, intervention, ECMO | Active comparator | Procedure: hypothermiaHypothermia + intervention |
| Hypothermia, no intervention, ECMO | Active comparator | Procedure: hypothermiaHypothermia without intervention after ECMO |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1. in cardiac arrest that necessitated external or open-chest cardiac massage and a large amount of epinephrine (>5 mg) during CPR.
- 2. Could not be returned to spontaneous circulation within 10 to 20 min
Key exclusion criteria (1 listed)
- contraindicated to ECMO use
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 |
|---|---|---|
| hypothermiaAlso: ECPRCore temperature --> 34.9℃ within 30 min --> 33.5℃ within 120min --> 33℃for 24 H Decrease temperature in 0.9℃/hour | Procedure or surgery | Hypothermia, intervention, ECMO, Hypothermia, no intervention, ECMO, No Hypothermia, No intervention, ECMO |
Primary outcome
1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death.
Time frame: 20091231
1 secondary outcome
Brain injury
Time frame: 20091231
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
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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.
Shaojung Li, physician principal investigator
Director, department of cardiovascular surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing hypothermia in people with Out-of-Hospital Cardiac Arrest, run by Min-Sheng General 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 2 inclusion and 1 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 25 Aug 2009. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Shaojung Li, physician (886-3-3179599 ext. 8528, shaojung@ms24.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death. (time frame: 20091231). 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 25 Aug 2009.