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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00347477
Enrollment
23
Registered
2006-07-04
Start date
2005-09-30
Completion date
2009-03-31
Last updated
2009-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

cardiac arrest, hypothermia, neurologic outcome, edema

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 (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.

Interventions

DRUGHyperHAES vs. RA-solution/NaCl

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Witnessed cardiac arrest, * ALS started within 15 min. * ROSC within 60 min. * Still unconscious, * Age 18-80

Exclusion criteria

* Other malignancies, * Persons who wake up, * Pregnancy

Design outcomes

Primary

MeasureTime frame
Mortality
Quality of Life

Secondary

MeasureTime frame
Days in the ICU
Neurological test as described
Grade of Edema

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026