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Organ Donation and Hydrocortisone Treatment (HYDRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00675272
Recruitment Status : Terminated (Routine use of corticoids became standard therapy)
First Posted : May 9, 2008
Last Update Posted : April 6, 2015
Tampere University Hospital
Information provided by (Responsible Party):
Stepani Bendel, Kuopio University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Death Drug: hydrocortisone Drug: sodium chloride Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment
Study Start Date : May 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: 1
hydrocortisone treatment 50mg iv x4
Drug: hydrocortisone
hydrocortisone 50mg iv. every 6 hours

Placebo Comparator: 2
Placebo iv every 6 hours
Drug: sodium chloride
sodium chloride every 6 hours iv

Primary Outcome Measures :
  1. dosage and time on norepinephrine treatment [ Time Frame: in ICU ]

Secondary Outcome Measures :
  1. Hormone levels and number of organs donated [ Time Frame: Hospital treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00675272

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Kuopio University Hospital
Kuopio, Finland, 70211
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Kuopio University Hospital
Tampere University Hospital
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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

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Responsible Party: Stepani Bendel, MD PhD, Kuopio University Hospital Identifier: NCT00675272     History of Changes
Other Study ID Numbers: KUH5070197
First Posted: May 9, 2008    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015
Keywords provided by Stepani Bendel, Kuopio University Hospital:
brain death
subarachnoid hemorrhage
traumatic brain injury
brain injury
intracerebral hemorrhage
organ donation
Additional relevant MeSH terms:
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Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Brain Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Anti-Inflammatory Agents