Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT00391469
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2006-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
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Effect of prehospital induction of mild hypothermia on 3-month neurological status and 1-year survival among adults with cardiac arrest: long-term follow-up of a randomized, clinical trial. J Am Heart Assoc. 2015 Mar 11;4(3):e001693. doi: 10.1161/JAHA.114.001693.'}, {'pmid': '24240712', 'type': 'DERIVED', 'citation': 'Kim F, Nichol G, Maynard C, Hallstrom A, Kudenchuk PJ, Rea T, Copass MK, Carlbom D, Deem S, Longstreth WT Jr, Olsufka M, Cobb LA. Effect of prehospital induction of mild hypothermia on survival and neurological status among adults with cardiac arrest: a randomized clinical trial. JAMA. 2014 Jan 1;311(1):45-52. doi: 10.1001/jama.2013.282173.'}, {'pmid': '24188226', 'type': 'DERIVED', 'citation': 'Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.'}, {'pmid': '17823147', 'type': 'DERIVED', 'citation': 'Soar J, Nolan JP. Mild hypothermia for post cardiac arrest syndrome. BMJ. 2007 Sep 8;335(7618):459-60. doi: 10.1136/bmj.39315.519201.BE.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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 who survive and are discharged awake from the hospital.\n\nHypothesis: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* successful resuscitation from out-of-hospital cardiac arrest by paramedics, defined by having a palpable pulse\n\nExclusion Criteria:\n\n* traumatic cause for cardiac arrest'}, 'identificationModule': {'nctId': 'NCT00391469', 'briefTitle': 'Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Study of the Use of Mild Hypothermia in Out-of-hospital Cardiac Arrest Using a Rapid Infusion of 2 Liters of Cold Normal Saline', 'orgStudyIdInfo': {'id': '29121-B'}, 'secondaryIdInfos': [{'id': 'R01HL089554', 'link': 'https://reporter.nih.gov/quickSearch/R01HL089554', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control treatment', 'interventionNames': ['Other: Rapid infusion of 2 liters of 4oC normal saline', 'Drug: Rapid infusion of cold normal saline']}], 'interventions': [{'name': 'Rapid infusion of 2 liters of 4oC normal saline', 'type': 'OTHER', 'otherNames': ['Rapid infusion of cold normal saline'], 'description': 'Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.', 'armGroupLabels': ['control treatment']}, {'name': 'Rapid infusion of cold normal saline', 'type': 'DRUG', 'armGroupLabels': ['control treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Francis Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Leonard Cobb, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medic One Foundation', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Francis Kim', 'investigatorAffiliation': 'University of Washington'}}}}