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Organ Donation and Hydrocortisone Treatment

Information source: Kuopio University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Death

Intervention: hydrocortisone (Drug); sodium chloride (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Kuopio University Hospital

Official(s) and/or principal investigator(s):
Stepani Bendel, MD, Study Director, Affiliation: Kuopio University Hospital
Esko Ruokonen, MD, PhD, Study Director, Affiliation: Kuopio University Hospital
Jyrki Tenhunen, MD, PhD, Study Chair, Affiliation: Tampere UH
Anna-Maija Antman, MD, Principal Investigator, Affiliation: Tampere UH


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.

Clinical Details

Official title: Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: dosage and time on norepinephrine treatment

Secondary outcome: Hormone levels and number of organs donated

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Kuopio University Hospital, Kuopio 70211, Finland

Tampere University Hospital, Tampere, Finland

Additional Information

Starting date: May 2008
Last updated: April 3, 2015

Page last updated: August 23, 2015

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