Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Rainer Oberbauer
ORCID ID
Contact details
Vienna Medical University
Waehringer Gürtel 18-20
Vienna
1090
Austria
+43 (0)140 400 4358
rainer.oberbauer@meduniwien.ac.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P-18325
Study information
Scientific title
Acronym
Study hypothesis
Deceased organ donors exhibit a severe systemic inflammatory response caused by the brain death syndrome. This leads to an activation of inflammatory regulators in the donor kidney, associated with increased risk for subsequent development of post-ischemic acute renal transplant failure (ARTF) in the recipient. ARTF is the main risk factor for shortened allograft survival. Pre-treatment of deceased organ donors with corticosteroids before organ retrieval may modify the genome-wide gene expression in the donor kidney and thus reduce the incidence and duration of post-ischemic ARTF after engraftment.
Ethics approval
Approved by the Ethics Committee of the Medical University Vienna on 14/03/2005, reference number: 067/2005
Study design
Randomised placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Pre-treatment of deceased organ donors
Intervention
The deceased organ donor will be randomized to receive 1000 mg of methylprednisolone or placebo three to six hours before organ retrieval. Donor kidney biopsies will be obtained before engraftment and genome-wide gene expression analysis will be performed using complementary deoxyribonucleic acid (cDNA) microarrays.
Intervention type
Drug
Phase
Not Specified
Drug names
Methylprednisolone
Primary outcome measures
Incidence and duration of post-ischemic acute renal transplant failure in the transplant recipient
Secondary outcome measures
Genome-wide gene expression analysis of transplant kidney wedge biopsies
Overall trial start date
20/03/2006
Overall trial end date
20/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Deceased kidney donors
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 deceased organ donors
Participant exclusion criteria
Non-heart beating organ donors
Recruitment start date
20/03/2006
Recruitment end date
20/09/2008
Locations
Countries of recruitment
Austria
Trial participating centre
Vienna Medical University
Vienna
1090
Austria
Sponsor information
Organisation
Austrian Science Fund
Sponsor details
Weyringergasse 35
Vienna
1040
Austria
+43 (0)1 505 67 40
office@fwf.ac.at
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Austrian Science Funds (grant P-18325)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20713790
Publication citations
-
Results
Kainz A, Wilflingseder J, Mitterbauer C, Haller M, Burghuber C, Perco P, Langer RM, Heinze G, Oberbauer R, Steroid pretreatment of organ donors to prevent postischemic renal allograft failure: a randomized, controlled trial., Ann. Intern. Med., 2010, 153, 4, 222-230, doi: 10.7326/0003-4819-153-4-201008170-00003.