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Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation.

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ClinicalTrials.gov Identifier: NCT00965016
Recruitment Status : Unknown
Verified August 2009 by Min-Sheng General Hospital.
Recruitment status was:  Recruiting
First Posted : August 25, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Min-Sheng General Hospital

Study Description
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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:

  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. 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.


Condition or disease Intervention/treatment Phase
Out-of-Hospital Cardiac Arrest Procedure: hypothermia Early Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Therapeutic Effect of Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation (ECPR).
Study Start Date : January 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

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Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: No Hypothermia, No intervention, ECMO
No hypothermia used during ECPR
 Procedure: hypothermia
Core temperature --> 34.9℃ within 30 min --> 33.5℃ within 120min --> 33℃for 24 H Decrease temperature in 0.9℃/hour
Other Name: ECPR
Active Comparator: Hypothermia, intervention, ECMO
Hypothermia + intervention
 Procedure: hypothermia
Core temperature --> 34.9℃ within 30 min --> 33.5℃ within 120min --> 33℃for 24 H Decrease temperature in 0.9℃/hour
Other Name: ECPR
Active Comparator: Hypothermia, no intervention, ECMO
Hypothermia without intervention after ECMO
 Procedure: hypothermia
Core temperature --> 34.9℃ within 30 min --> 33.5℃ within 120min --> 33℃for 24 H Decrease temperature in 0.9℃/hour
Other Name: ECPR


Outcome Measures
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Primary Outcome Measures :
  1. 1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death. [ Time Frame: 20091231 ]

Secondary Outcome Measures :
  1. Brain injury [ Time Frame: 20091231 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00965016


Contacts
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Contact: Shaojung Li, physician 886-3-3179599 ext 8528 shaojung@ms24.hinet.net

Locations
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Taiwan
Min-sheng General Hospital Recruiting
Taoyuan, Taiwan, 330
Contact: Yao, Physician    886-3-3179599 ext 2007      
Sponsors and Collaborators
Min-Sheng General Hospital
Investigators
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Principal Investigator: Shaojung Li, physician Director, department of cardiovascular surgery
More Information
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Responsible Party: Yao, Director of department of Education, Min-Sheng General Hospital
ClinicalTrials.gov Identifier: NCT00965016    
Other Study ID Numbers: MSEIRB0980106
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009
Keywords provided by Min-Sheng General Hospital:
Extracorporeal membrane oxygenation，induced hypothermia
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Hypothermia
 Heart Diseases
Cardiovascular Diseases
Body Temperature Changes