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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • dosage and time on norepinephrine treatment [ Time Frame: in ICU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hormone levels and number of organs donated [ Time Frame: Hospital treatment ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: May 2008
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stepani Bendel, MD PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00675272     History of Changes
Other Study ID Numbers: KUH5070197
Study First Received: May 7, 2008
Last Updated: December 8, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
brain death
subarachnoid hemorrhage
traumatic brain injury
 brain injury
intracerebral hemorrhage
organ donation

Additional relevant MeSH terms:
Brain Death
Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
 Pathologic Processes
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013