Organ Donation and Hydrocortisone Treatment
Information source: Kuopio University Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Death
Intervention: hydrocortisone (Drug); sodium chloride (Drug)
Phase: N/A
Status: Recruiting
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
Overall contact:
Stepani Bendel, MD, Phone: 358-1717-3311, Email: Stepani.Bendel@kuh.fi
Summary
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, Control: Placebo Control, 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Stepani Bendel, MD, Phone: 358-1717-3311, Email: Stepani.Bendel@kuh.fi
Kuopio University Hospital, Kuopio 70211, Finland; Recruiting
Stepani Bendel, MD, Phone: 358-1717-3311, Email: stepani.bendel@kuh.fi
Stepani Bendel, MD, Principal Investigator
Esko Ruokonen, MD,PhD, Sub-Investigator
Ilkka Parviainen, MD,PhD, Sub-Investigator
Juha J Jääskeläinen, MD, PhD, Sub-Investigator
Timo Koivisto, MD,PhD, Sub-Investigator
Tampere University Hospital, Tampere, Finland; Recruiting
Jyrki Tenhunen, MD,PhD, Email: Jyrki.Tenhunen@pshp.fi
Jyrki Tenhunen, MD,PhD, Principal Investigator
Anna-Maija Antman, MD, Principal Investigator
Juha Öhman, MD,PhD, Sub-Investigator
Additional Information
Starting date: May 2008
Last updated: August 17, 2010
|
