Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation.
Primary Purpose
Out-of-Hospital Cardiac Arrest
Status
Unknown status
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
hypothermia
Sponsored by
About this trial
This is an interventional treatment trial for Out-of-Hospital Cardiac Arrest focused on measuring Extracorporeal membrane oxygenation,induced hypothermia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- contraindicated to ECMO use
Sites / Locations
- Min-sheng General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Active Comparator
Arm Label
No Hypothermia, No intervention, ECMO
Hypothermia, intervention, ECMO
Hypothermia, no intervention, ECMO
Arm Description
No hypothermia used during ECPR
Hypothermia + intervention
Hypothermia without intervention after ECMO
Outcomes
Primary Outcome Measures
1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death.
Secondary Outcome Measures
Brain injury
Full Information
NCT ID
NCT00965016
First Posted
August 23, 2009
Last Updated
August 23, 2009
Sponsor
Min-Sheng General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00965016
Brief Title
Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation.
Official Title
The Therapeutic Effect of Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation (ECPR).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Min-Sheng General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest
Keywords
Extracorporeal membrane oxygenation,induced hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No Hypothermia, No intervention, ECMO
Arm Type
Sham Comparator
Arm Description
No hypothermia used during ECPR
Arm Title
Hypothermia, intervention, ECMO
Arm Type
Active Comparator
Arm Description
Hypothermia + intervention
Arm Title
Hypothermia, no intervention, ECMO
Arm Type
Active Comparator
Arm Description
Hypothermia without intervention after ECMO
Intervention Type
Procedure
Intervention Name(s)
hypothermia
Other Intervention Name(s)
ECPR
Intervention Description
Core temperature --> 34.9℃ within 30 min --> 33.5℃ within 120min --> 33℃for 24 H Decrease temperature in 0.9℃/hour
Primary Outcome Measure Information:
Title
1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death.
Time Frame
20091231
Secondary Outcome Measure Information:
Title
Brain injury
Time Frame
20091231
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
contraindicated to ECMO use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaojung Li, physician
Phone
886-3-3179599
Ext
8528
Email
shaojung@ms24.hinet.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaojung Li, physician
Organizational Affiliation
Director, department of cardiovascular surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Min-sheng General Hospital
City
Taoyuan
ZIP/Postal Code
330
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao, Physician
Phone
886-3-3179599
Ext
2007
12. IPD Sharing Statement
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Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation.
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