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Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT00347477
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : May 1, 2009
Sponsor:
Information provided by:
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE June 30, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date May 1, 2009
Study Start Date  ICMJE September 2005
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
  • Mortality
  • Quality of Life
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00347477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
  • Days in the ICU
  • Neurological test as described
  • Grade of Edema
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest
Official Title  ICMJE Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest
Intervention  ICMJE Drug: HyperHAES vs. RA-solution/NaCl
Study Arms  ICMJE Not Provided
Publications * Heradstveit BE, Guttormsen AB, Langørgen J, Hammersborg SM, Wentzel-Larsen T, Fanebust R, Larsson EM, Heltne JK. Capillary leakage in post-cardiac arrest survivors during therapeutic hypothermia - a prospective, randomised study. Scand J Trauma Resusc Emerg Med. 2010 May 25;18:29. doi: 10.1186/1757-7241-18-29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
23
Original Enrollment  ICMJE
 (submitted: June 30, 2006)
18
Study Completion Date  ICMJE March 2009
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347477
Other Study ID Numbers  ICMJE 12080
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bård E Heradstveit, MD, Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jon k Heltne, Dr.med AKuttmedisin/KSK/ Haukeland University Hosp.
PRS Account Haukeland University Hospital
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP