Organ Donation and Hydrocortisone Treatment - Full Text View

Sponsor:	Kuopio University Hospital
Collaborator:	University Hospital
Information provided by:	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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment

Resource links provided by NLM:

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 ]

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator hydrocortisone treatment 50mg iv x4	Drug: hydrocortisone hydrocortisone 50mg iv. every 6 hours
2: Placebo Comparator 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

Contacts

Contact: Stepani Bendel, MD	358-1717-3311	Stepani.Bendel@kuh.fi
Contact: Esko Ruokonen, MD,PhD	358-1717-3311	Esko.Ruokonen@kuh.fi

Locations

Finland
Kuopio University Hospital	Recruiting
KUOPIO, Finland, 70211
Contact: Stepani Bendel, MD 358-1717-3311 stepani.bendel@kuh.fi
Principal Investigator: Stepani Bendel, MD
Sub-Investigator: Esko Ruokonen, MD,PhD
Sub-Investigator: Ilkka Parviainen, MD,PhD
Sub-Investigator: Juha J Jääskeläinen, MD, PhD
Sub-Investigator: Timo Koivisto, MD,PhD
Tampere University Hospital	Recruiting
Tampere, Finland
Contact: Jyrki Tenhunen, MD,PhD Jyrki.Tenhunen@pshp.fi
Principal Investigator: Jyrki Tenhunen, MD,PhD
Principal Investigator: Anna-Maija Antman, MD
Sub-Investigator: Juha Öhman, MD,PhD

Sponsors and Collaborators

Kuopio University Hospital

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:	Deparment of Intensice Care, Kuopio University Hospital, Finland ( Stepani Bendel )
Study ID Numbers:	KUH5070197
Study First Received:	May 7, 2008
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00675272 History of Changes
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:

Anti-Inflammatory Agents
Unconsciousness
Death
Hydrocortisone
Brain Death
Cortisol succinate
Nervous System Diseases
Consciousness Disorders
Central Nervous System Diseases

Brain Diseases
Pharmacologic Actions
Coma
Pathologic Processes
Therapeutic Uses
Neurologic Manifestations
Hydrocortisone acetate
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on February 09, 2010