A Phase 3 interventional study of HyperHAES vs. RA-solution/NaCl in Cardiac Arrest, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-05-01.
Sponsored by Haukeland University Hospital · Phase 3, Interventional, and Treatment
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.
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 23 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mortality
Quality of Life
Days in the ICU
Neurological test as described
Grade of Edema
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Haukeland University Hospital