| Trial ID: | L1053 |
| Source ID: | NCT00337051
|
| Associated Drug: |
Sevoflurane
|
| Title: |
Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN)
|
| Acronym: |
SévoRein
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-stage Chronic Renal Disease|Severe Acute Kidney Failure|Renal Transplantation
|
| Interventions: |
DRUG: Sevoflurane|DRUG: Propofol
|
| Outcome Measures: |
Primary: time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient, evalued at 14 days | Secondary: creatinemia levels at day 14, evalued at 14 days|patient survival, during 1 year follow-up|acute rejection occurrence, during 1 year follow-up|safety : renal tubular injury toxicity (serum cystatinC and NAG), serum inorganic fluor products, 1, 2 and 3 days after kidney transplantation|other clinical end-points: daily diuresis, number of haemodialysis sessions, during the two weeks following transplantation|other biological end-points: serum creatinin and cystatinC levels, during the two weeks following transplantation|Other adverse events, during one year folow-up
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Bordeaux | Collaborators: Ministry of Health, France
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-06
|
| Completion Date: |
2010-06
|
| Results First Posted: |
|
| Last Update Posted: |
2010-06-23
|
| Locations: |
Département d'anesthésie réanimation 1 - Hôpital Pellegrin - CHU de Bordeaux, Bordeaux, 33076, France
|
| URL: |
https://clinicaltrials.gov/show/NCT00337051
|
