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Organ Donation and Hydrocortisone Treatment (HYDRO)

This study has been terminated.
(Routine use of corticoids became standard therapy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675272
First Posted: May 9, 2008
Last Update Posted: April 6, 2015
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.
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Stepani Bendel, Kuopio University Hospital
  Purpose
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 Intervention
Brain Death Drug: hydrocortisone Drug: sodium chloride

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Stepani Bendel, Kuopio University Hospital:

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

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

Enrollment: 38
Study Start Date: May 2008
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00675272


Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Kuopio University Hospital
Tampere University Hospital
Investigators
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
  More Information

Responsible Party: Stepani Bendel, MD PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00675272     History of Changes
Other Study ID Numbers: KUH5070197
First Submitted: May 7, 2008
First Posted: May 9, 2008
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:
Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents