Immunosuppression regimen reduction in kidney transplantation recipients admitted to the intensive care unit in the setting of septic shock and/or acute respiratory failure: an open multicentric randomized phase IV study

kidney transplant

The primary endpoint is the rate of patients showing a reduction in the SOFA (Sequential Organ Failure Assessment) score of at least 4 points at day 5

Vital status at discharge from the ICU and at month 6, Daily evolution of the SOFA score (from day 1 to day 7), Serum creatinine level and glomerular filtration rate (GFR, in ml/min) at discharge from the ICU, assessed by the UV/P method (urine creatinine * diuresis / plasma creatinine). Given the usual collection of 24-hour urine in intensive care, this cost-effective approach is easily achievable and is the most relevant in intensive care, Dialysis status (during ICU stay and at month 6): use of dialysis, modality of dialysis, weaning from RRT at discharge between ICU discharge and month 6, Histological evidence (graft biopsy) and characterization of rejection according to the Banff classification, for any sample taken between discharge from the ICU and month 6 (biopsy for cause only)., Evaluation of anti-HLA immunization will be performed on a blood sample at month 6, with screening for Donor-Specific Antibodies, Collection of significant infection episodes from ICU discharge to month 6. An infection will be considered significant if it requires hospitalization. Additionally, during the 6-month consultation, blood replication for CMV, EBV, and BK virus and urinary replication of BK virus (assessed with Polymerase Chain Reaction tests) will be collected as part of routine care

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

France