Pre-treatment of deceased organ donors with methylprednisolone versus placebo for the prevention of post-ischemic acute renal transplant failure
| ISRCTN | ISRCTN78828338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78828338 |
| Secondary identifying numbers | P-18325 |
- Submission date
- 14/03/2006
- Registration date
- 12/04/2006
- Last edited
- 04/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rainer Oberbauer
Scientific
Scientific
Vienna Medical University
Waehringer Gürtel 18-20
Vienna
1090
Austria
| Phone | +43 (0)140 400 4358 |
|---|---|
| rainer.oberbauer@meduniwien.ac.at |
Study information
| Study design | Randomised placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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(s) | Approved by the Ethics Committee of the Medical University Vienna on 14/03/2005, reference number: 067/2005 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methylprednisolone |
| Primary outcome measure | 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 study start date | 20/03/2006 |
| Completion date | 20/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 deceased organ donors |
| Key inclusion criteria | Deceased kidney donors |
| Key exclusion criteria | Non-heart beating organ donors |
| Date of first enrolment | 20/03/2006 |
| Date of final enrolment | 20/09/2008 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna Medical University
Vienna
1090
Austria
1090
Austria
Sponsor information
Austrian Science Fund
Government
Government
Weyringergasse 35
Vienna
1040
Austria
| Phone | +43 (0)1 505 67 40 |
|---|---|
| office@fwf.ac.at | |
| Website | http://www.fwf.ac.at |
"ROR" |
https://ror.org/013tf3c58 |
Funders
Funder type
Government
Austrian Science Funds (grant P-18325)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/08/2010 | Yes | No |
