Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

NCT ID: NCT00347477

Last Updated: 2009-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-03-31

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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

HyperHAES vs. RA-solution/NaCl

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Haukeland University Hospital

Principal Investigators

Jon k Heltne, Dr.med

Role: STUDY_CHAIR

AKuttmedisin/KSK/ Haukeland University Hosp.

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 20500876 (View on PubMed)

Other Identifiers

12080

Identifier Type: -

Identifier Source: org_study_id