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

August 23, 2009 updated by: Min-Sheng General Hospital

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:

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 330
        • Recruiting
        • Min-Sheng General Hospital
        • Contact:
          • Yao, Physician
          • Phone Number: 2007 886-3-3179599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • ECPR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death.
Time Frame: 20091231
20091231

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Brain injury
Time Frame: 20091231
20091231

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Min-Sheng General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shaojung Li, physician, Director, department of cardiovascular surgery

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2009

More Information

Terms related to this study

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Other Study ID Numbers

Other Study ID Numbers

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  • MSEIRB0980106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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