Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282373
Status:
COMPLETED
Last Update Posted:
2007-09-11
First Post:
2006-01-24
Brief Title:
Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients
Sponsor:
Medivance Inc
Organization:
Medivance Inc
Study Overview
Official Title:
Randomized Controlled Pilot Study Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients Using Traditional Surface Cooling Techniques vs the Medivance Arctic Sun System
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are to determine the safety and feasibility of inducing mild hypothermia using a non-invasive thermoregulatory device the Medivance Arctic Sun Temperature Management System in patients resuscitated after cardiac arrest
Detailed Description:
Extensive research has been conducted in the use of mild hypothermia as a neuroprotectant in acute brain injury in animal models with studies having been initiated as far back as the 1950s However little work had been done in the area of therapeutic hypothermia and cardiac arrest
In the early 80s the Pittsburgh group resurrected the work with the induction of hypothermia in animals The discovery of mild resuscitative hypothermia provided evidence that the main mechanism by which hypothermia can help resuscitate the brain after normothermic cardiac arrest is a synergistic effect of the suppression of deleterious chemical cascades energy loss depolarization calcium influx excitotoxicity free radical reactions membrane failure DNA fragmentation and damage to the mitochondria
Recently the study Mild hypothermia to improve the neurologic outcome after cardiac arrest from the Hypothermia After Cardiac Arrest Study Group New Engl J Med 2002346549-556 reported the results of a multicenter randomized controlled clinical trial that evaluated the effect of mild systemic hypothermia on mortality and functional outcome after resuscitation from out-of-hospital cardiac arrest due to ventricular fibrillation or tachycardia Two hundred and seventy three patients were randomly assigned to standard normothermic or hypothermic management Cooling to a target core body temperature of 32ºC to 34ºC was accomplished with the use of a specialized bed which delivers cold air over the entire body Temperature was maintained in the target range for 24 hours after the start of cooling followed by passive rewarming over 8 hours Outcome was assessed at 6 months with a five point scale similar to the Glasgow Outcome Scale dichotomized to classify independent patients with minimal or moderate disability to those who were dependent and severely disabled vegetative or dead The results demonstrated a favorable neurological outcome in 55 of the 136 patients treated with hypothermia compared to 39 of the 137 patients treated with normothermic management risk ratio 140 95 confidence interval 108 to 181 P009 Mortality was also reduced with hypothermic management from 41 in the hypothermia group to 55 in the normothermia group risk ratio 074 95 confidence interval 058 to 085 P02 In 19 patients 14 the target temperature could not be reached Complications did not differ significantly between the two groups although there were trends toward increased rates of sepsis and bleeding with hypothermia
Based upon the body of published evidence to date the Advanced Life Support ALS Task Force of the International Liaison Committee on Resuscitation ILCOR made the following recommendations in October 2002 Resuscitation 57 2003 231-235
Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32-34C for 12 -24 hours when the initial rhythm is ventricular fibrillation VF
Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest
The study is a prospective randomized multi-center pilot study of the Arctic Sun System used as adjunctive therapy in patients resuscitated post cardiac arrest
Patients who meet the inclusion criteria and for whom informed consent has been provided by an authorized representativefamily member will be randomly assigned to either the control group traditional cooling blankets and ice or the experimental group Arctic Sun Temperature Management System
Patients will be cooled to a target range of 335C to 339C The patient cooling will continue for 24 hours from the initiation of cooling and then gradually rewarmed to 360C over approximately 6 to 12 hours
In the early 80s the Pittsburgh group resurrected the work with the induction of hypothermia in animals The discovery of mild resuscitative hypothermia provided evidence that the main mechanism by which hypothermia can help resuscitate the brain after normothermic cardiac arrest is a synergistic effect of the suppression of deleterious chemical cascades energy loss depolarization calcium influx excitotoxicity free radical reactions membrane failure DNA fragmentation and damage to the mitochondria
Recently the study Mild hypothermia to improve the neurologic outcome after cardiac arrest from the Hypothermia After Cardiac Arrest Study Group New Engl J Med 2002346549-556 reported the results of a multicenter randomized controlled clinical trial that evaluated the effect of mild systemic hypothermia on mortality and functional outcome after resuscitation from out-of-hospital cardiac arrest due to ventricular fibrillation or tachycardia Two hundred and seventy three patients were randomly assigned to standard normothermic or hypothermic management Cooling to a target core body temperature of 32ºC to 34ºC was accomplished with the use of a specialized bed which delivers cold air over the entire body Temperature was maintained in the target range for 24 hours after the start of cooling followed by passive rewarming over 8 hours Outcome was assessed at 6 months with a five point scale similar to the Glasgow Outcome Scale dichotomized to classify independent patients with minimal or moderate disability to those who were dependent and severely disabled vegetative or dead The results demonstrated a favorable neurological outcome in 55 of the 136 patients treated with hypothermia compared to 39 of the 137 patients treated with normothermic management risk ratio 140 95 confidence interval 108 to 181 P009 Mortality was also reduced with hypothermic management from 41 in the hypothermia group to 55 in the normothermia group risk ratio 074 95 confidence interval 058 to 085 P02 In 19 patients 14 the target temperature could not be reached Complications did not differ significantly between the two groups although there were trends toward increased rates of sepsis and bleeding with hypothermia
Based upon the body of published evidence to date the Advanced Life Support ALS Task Force of the International Liaison Committee on Resuscitation ILCOR made the following recommendations in October 2002 Resuscitation 57 2003 231-235
Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32-34C for 12 -24 hours when the initial rhythm is ventricular fibrillation VF
Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest
The study is a prospective randomized multi-center pilot study of the Arctic Sun System used as adjunctive therapy in patients resuscitated post cardiac arrest
Patients who meet the inclusion criteria and for whom informed consent has been provided by an authorized representativefamily member will be randomly assigned to either the control group traditional cooling blankets and ice or the experimental group Arctic Sun Temperature Management System
Patients will be cooled to a target range of 335C to 339C The patient cooling will continue for 24 hours from the initiation of cooling and then gradually rewarmed to 360C over approximately 6 to 12 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None