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Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347477
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : May 1, 2009
Information provided by:
Haukeland University Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Drug: HyperHAES vs. RA-solution/NaCl Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?
Study Start Date : September 2005
Actual Primary Completion Date : April 2007
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Mortality
  2. Quality of Life

Secondary Outcome Measures :
  1. Days in the ICU
  2. Neurological test as described
  3. Grade of Edema

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347477

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Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
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Study Chair: Jon k Heltne, AKuttmedisin/KSK/ Haukeland University Hosp.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bård E Heradstveit, MD, Haukeland University Hospital Identifier: NCT00347477    
Other Study ID Numbers: 12080
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: March 2009
Keywords provided by Haukeland University Hospital:
cardiac arrest
neurologic outcome
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms