Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347477
• Other study ID #: 12080
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2006
• Last updated: April 30, 2009
• Start date: September 2005
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2009
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Intervention

Drug:
• HyperHAES vs. RA-solution/NaCl

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Primary	Quality of Life
Secondary	Days in the ICU
Secondary	Neurological test as described
Secondary	Grade of Edema