To investigate the effects of immunosuppressant reduction (comparison between discontinuation and half-dose reduction of mycophenolate) and infection outcomes in kidney transplant recipients experiencing sepsis Kidney transplant, infection, sepsis, immunosuppression, immunosuppressant reduction
Conditions
Interventions
Half dose reduction of the current mycophenolate dose,Discontinuation of mycophenolate
Experimental Drug,Active Comparator Drug
Half dose reduction of the current dose,Discontinuation of mycophenolate
Sponsors
Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years old or above 2. Recipients of kidney transplants for over one month who are on a maintenance immunosuppressive regimen that includes calcineurin inhibitors, mycophenolate, and corticosteroids 3. Meet the criteria of sepsis according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) a. Suspected or documented infection b. Acute increase of more than 2 SOFA points from the most recent value
Exclusion criteria
Exclusion criteria: 1. Previous or active cytomegalovirus infection within 3 months 2. Previous or active BK virus nephropathy within 3 months 3. Neutropenia: Absolute neutrophil count (ANC) <1,500 /cu.mm at enrollment 4. Severe septic shock requires a high dose of inotropic drugs within 24 hours after enrollment, including a. Norepinephrine >0.5 mcg/kg/min b. Epinephrine >0.5 mcg/kg/min c. Dopamine >10 mcg/kg/min 5. Severe acute respiratory distress syndrome (ARDS): PF ratio <100 within 24 hours after enrollment 6. Contraindicated for enteral medication within 24 hours after enrollment 7. Baseline eGFR <15 mL/min/1.73 m2 8. Advanced malignancy (solid and hematologic malignancy) 9. Cirrhosis 10. Uncontrolled psychiatric disease or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of in-hospital mortality, or failure to achieve at least 25% decrease of admission SOFA at day 7 During admission Mortality, The Sequential Organ Failure Assessment (SOFA) Score | — |
Secondary
| Measure | Time frame |
|---|---|
| In-hospital mortality During admission Mortality,Failure to achieve at least 25% decrease of admission SOFA at day 7 7 day The Sequential Organ Failure Assessment (SOFA) Score,Failure to achieve at least 80% decrease of admission procalcitonin at day 4 4 day Serum procalcitonin,Failure to achieve APACHE II score less than 17 at day 3 3 day APACHE II (Acute Physiology And Chronic Health Evaluation) score,90-day mortality, 1-year mortality, and time to mortality Within 1 year Mortality,Time to rehospitalization and cause of rehospitalization Within 1 year Admission record,Length of stay During admission Duration of admission,Termination of treatment protocol During admission Record of termination,Incidence and duration of renal replacement therapy during admission During admission Renal replacement therapy,Time to allograft failure Within 1 year Need for long term renal replacement therapy,Time to biopsy-proven acute rejection Within 1 year Kidney pathology ,Time to sustained doubling serum creatinine (more than 3 months) Within 1 year Serum creatinine | — |
Countries
Thailand
Contacts
Public ContactTeerawat Sriwalosakul
Faculty of Medicine, Chiang Mai University
Outcome results
None listed