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Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

This study has been completed.
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00347477
First received: June 30, 2006
Last updated: April 30, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Cardiac Arrest
 Drug: HyperHAES vs. RA-solution/NaCl
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Mortality
  • Quality of Life

Secondary Outcome Measures:
  • Days in the ICU
  • Neurological test as described
  • Grade of Edema

Estimated Enrollment: 23
Study Start Date: September 2005
Estimated Study Completion Date: March 2009
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347477

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Chair: Jon k Heltne, Dr.med AKuttmedisin/KSK/ Haukeland University Hosp.
  More Information

No publications provided by Haukeland University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bård E Heradstveit, MD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00347477     History of Changes
Other Study ID Numbers: 12080
Study First Received: June 30, 2006
Last Updated: April 30, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
cardiac arrest
hypothermia
neurologic outcome
edema

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
 Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013