Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00457431
Status:
TERMINATED
Last Update Posted:
2021-06-22
First Post:
2007-04-04
Brief Title:
Hypothermia After In-hospital Cardiac Arrest
Sponsor:
University Hospital Schleswig-Holstein
Organization:
University Hospital Schleswig-Holstein
Study Overview
Official Title:
Hypothermia After In-hospital Cardiac Arrest
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
interim analysis with stopping for futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HACAinhospital
Brief Summary:
ILCOR Recommendations On the basis of the 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 Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32C to 34C for 12 to 24 hours when the initial rhythm was ventricular fibrillation VFSuch cooling may also be beneficial for other rhythms or in-hospital cardiac arrest Circulation 2003108118-121 This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest
Detailed Description:
This is a randomized controlled multicenter trial Patients after in-hospital cardiac arrest are randomized either to standard therapy or to standard therapy in addition to mild therapeutic hypothermia Mild therapeutic hypothermia is performed for 24 hours with a target temperature of 32-34C Inclusion criteria are Adult patients which have been resuscitated after cardiac arrest in-hospital and who remain unconscious after restoration of spontanous circulation Exclusion criteria are severe cardiogenic shock severe rhythm disorders major surgery within the last 10 days planned surgery within the next 24 hours afer resuscitation active bleeding suspicion od intracranial bleeding severe infection such as pneumonia or sepsis a severe neurological deficit before cardiac arrest an aquired immun deficency pregnacy The primary endpoint is mortality for all causes after six months Secondary endpoints are neurological outcome after six months measured by the Glasgow-Pittsburgh Cerebral Performance scale and in-hospital-mortality
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