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Organ Donation and Hydrocortisone Treatment (HYDRO)

This study has been terminated.
(Routine use of corticoids became standard therapy in many cases and this would have prolonged recruitment)
Sponsor:
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Stepani Bendel, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00675272
First received: May 7, 2008
Last updated: December 8, 2011
Last verified: December 2011
History of Changes

May 7, 2008
December 8, 2011
May 2008
August 2011   (final data collection date for primary outcome measure)
dosage and time on norepinephrine treatment [ Time Frame: in ICU ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675272 on ClinicalTrials.gov Archive Site
Hormone levels and number of organs donated [ Time Frame: Hospital treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Organ Donation and Hydrocortisone Treatment
Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment

Brain death patients who are selected for organ donation very often suffer from haemodynamic instability. To treat this, high amounts of vasoactive drugs(norepinephrine) may be needed to raise blood pressure. However,norepinephrine may have negative influence on several organs causing reduced blood flow ischemia. Our hypothesis is that hydrocortisone treatment may reduce the amount of vasoactive drugs needed to keep the blood pressure stable in patients selected for organ donation.

When patients are treated in the ICU only as possible organ donators they will be assessed for eligibility for the study. Iv hydrocortisone or placebo will be administered every 6 hours. Several hormonal samples will be collected.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Brain Death
  • Drug: hydrocortisone
    hydrocortisone 50mg iv. every 6 hours
  • Drug: sodium chloride
    sodium chloride every 6 hours iv
  • Active Comparator: 1
    hydrocortisone treatment 50mg iv x4
    Intervention: Drug: hydrocortisone
  • Placebo Comparator: 2
    Placebo iv every 6 hours
    Intervention: Drug: sodium chloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
38
December 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria: all have to be fulfilled

  • severe brain injury or subarachnoid hemorrhage which progrediates to brain death and patients are treated only as candidates for organ donation in the ICU
  • no other reasons for treatment than organ donation
  • informed consent from official representative

Exclusion Criteria:

  • age under 18
  • pregnancy
  • corticoid treatment before study entry
  • adrenal insufficiency
  • hypophyseal insufficiency
  • treatment with etomidate one week before study entry
  • participating in an other study
  • no informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00675272
KUH5070197
No
Stepani Bendel, Kuopio University Hospital
Kuopio University Hospital
Tampere University Hospital
Study Director: Stepani Bendel, MD Kuopio University Hospital
Study Director: Esko Ruokonen, MD, PhD Kuopio University Hospital
Study Chair: Jyrki Tenhunen, MD, PhD Tampere UH
Principal Investigator: Anna-Maija Antman, MD Tampere UH
Kuopio University Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP