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Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
HyperHAES vs. RA-solution/NaCl
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, hypothermia, neurologic outcome, edema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Outcomes

Primary Outcome Measures

Mortality
Quality of Life

Secondary Outcome Measures

Days in the ICU
Neurological test as described
Grade of Edema

Full Information

First Posted
June 30, 2006
Last Updated
April 30, 2009
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00347477
Brief Title
Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest
Official Title
Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
March 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Haukeland University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, hypothermia, neurologic outcome, edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HyperHAES vs. RA-solution/NaCl
Primary Outcome Measure Information:
Title
Mortality
Title
Quality of Life
Secondary Outcome Measure Information:
Title
Days in the ICU
Title
Neurological test as described
Title
Grade of Edema

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon k Heltne, Dr.med
Organizational Affiliation
AKuttmedisin/KSK/ Haukeland University Hosp.
Official's Role
Study Chair
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20500876
Citation
Heradstveit BE, Guttormsen AB, Langorgen 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.
Results Reference
derived

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Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

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