Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347477
Status:
COMPLETED
Last Update Posted:
2009-05-01
First Post:
2006-06-30
Brief Title:
Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest and How do They Manage Life Afterwards
Status:
COMPLETED
Status Verified Date:
2009-03
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:
Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a significant way However hypothermia also causes leak of fluid into the surrounding tissue This edema could lead to damage to the same tissue not beneficial for the patients We therefore try to evaluate if hyperosmolar hyperoncotic fluid as an alternative to std treatment NaClRAcould affect the edema in a positive way and result to a better outcome neurological for the patients
Detailed Description:
After the patients are admitted to our hospital we randomise them to either std fluid therapy NaClRA or HyperHAES After PCI we state the rate of cerebral edema by carrying out a cerebral MRI before the cooling starts We treat the patients with the different fluids for 24 hours We then evaluate the edema after 24 and 72 hours by the same method In addition we state the rate of peripheral capillary leak by WickS method The capillary leak is calculated every 8th hour for the 1 day the patients are treated in our ICU AFter 1 year those who survive are invited to a follow-up where we test the patient using Mini MEntal Status SF-36 in addition to neurophysiological tests as EEG and the P300-test We then relate the results to the fluid given initially after the cardiac arrest
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