Clinical Trials Directory

Trials / Completed

CompletedNCT00347477

Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
23 (estimated)
Sponsor
Haukeland University Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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 (NaCl/RA)could 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 (NaCl/RA) 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 Wick'S method. The capillary leak is calculated every 8.th 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.

Conditions

Interventions

TypeNameDescription
DRUGHyperHAES vs. RA-solution/NaCl

Timeline

Start date
2005-09-01
Primary completion
2007-04-01
Completion
2009-03-01
First posted
2006-07-04
Last updated
2009-05-01

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT00347477. Inclusion in this directory is not an endorsement.