NCT00347477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 1, 2009

Status Verified

March 1, 2009

Enrollment Period

1.6 years

First QC Date

June 30, 2006

Last Update Submit

April 30, 2009

Conditions

Cardiac Arrest

Keywords

cardiac arresthypothermianeurologic outcomeedema

Outcome Measures

Primary Outcomes (2)

  • Mortality

  • Quality of Life

Secondary Outcomes (3)

  • Days in the ICU

  • Neurological test as described

  • Grade of Edema

Interventions

HyperHAES vs. RA-solution/NaClDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Witnessed cardiac arrest,
  • ALS started within 15 min.
  • ROSC within 60 min.
  • Still unconscious,
  • Age 18-80

You may not qualify if:

  • Other malignancies,
  • Persons who wake up,
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

  • 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.

    PMID: 20500876DERIVED

MeSH Terms

Conditions

Heart ArrestHypothermiaEdema

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jon k Heltne, Dr.med

    AKuttmedisin/KSK/ Haukeland University Hosp.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

September 1, 2005

Primary Completion

April 1, 2007

Study Completion

March 1, 2009

Last Updated

May 1, 2009

Record last verified: 2009-03

Locations

NO(1)