Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
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| First Received Date ICMJE | October 20, 2006 | ||||||||
| Last Updated Date | January 25, 2013 | ||||||||
| Start Date ICMJE | December 2007 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
awake and able to follow commands at hospital discharge [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
survival at hospital discharge | ||||||||
| Change History | Complete list of historical versions of study NCT00391469 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
days to awakening, days to death, neurologic outcome [ Time Frame: at time of discharge, at 3 months following discharge ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
days to awakening, days to death, neurologic outcome | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest | ||||||||
| Official Title ICMJE | Study of the Use of Mild Hypothermia in Out-of-hospital Cardiac Arrest Using a Rapid Infusion of 2 Liters of Cold Normal Saline | ||||||||
| Brief Summary | The overall goal of this study is to determine whether initiating hypothermia in cardiac arrest patients as soon as possible in the field results in a greater proportion of patients who survive to hospital discharge compared to standard prehospital/field care. |
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| Detailed Description | In this study we will randomize 1,200 cardiac arrest patients who have return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objective of this study will be to determine whether induction of mild hypothermia using an infusion of cold normal saline will improve the proportion of patients discharged awake from the hospital. Hypothesis: In cardiac arrest patients who achieve ROSC in the field, initiation of hypothermia by infusion of cold normal saline will result in a greater proportion of cardiac arrest patients discharged awake from the hospital compared to standard care. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Out-of-hospital Cardiac Arrest | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | No Intervention: control treatment
Interventions:
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| Publications * | Soar J, Nolan JP. Mild hypothermia for post cardiac arrest syndrome. BMJ. 2007 Sep 8;335(7618):459-60. No abstract available. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 1364 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00391469 | ||||||||
| Other Study ID Numbers ICMJE | 29121-B, R01HL089554 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Francis Kim, University of Washington | ||||||||
| Study Sponsor ICMJE | University of Washington | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Washington | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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