Organ Donation and Hydrocortisone Treatment - Full Text View

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 )

First Received on May 7, 2008. Last Updated on December 8, 2011 History of Changes

Sponsor:	Kuopio University Hospital
Collaborator:	Tampere University Hospital
Information provided by (Responsible Party):	Stepani Bendel, Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00675272

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:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

Drug Information available for: Hydrocortisone acetate Hydrocortisone Chlorides Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate Sodium chloride

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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012