- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347477
Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest
April 30, 2009 updated by: Haukeland University Hospital
Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
23
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bergen, Norway, 5021
- Haukeland University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Mortality
|
Quality of Life
|
Secondary Outcome Measures
Outcome Measure |
---|
Days in the ICU
|
Neurological test as described
|
Grade of Edema
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jon k Heltne, Dr.med, AKuttmedisin/KSK/ Haukeland University Hosp.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
April 1, 2007
Study Completion
March 1, 2009
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
June 30, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
May 1, 2009
Last Update Submitted That Met QC Criteria
April 30, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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