Acute Kidney Injury, Sepsis
Conditions
Keywords
septic acute kidney injury, pirfenidone
Brief summary
Patients with Septic AKI will be randomized in three arms, group PFD 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive PFD 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days, all receive conventional treatment KDIGO guides. We analyze the recovery of renal function as a primary objective.
Detailed description
Septic acute kidney injury (AKI) is the most common cause of AKI in the world, there is no specific treatment for this pathology; the pathophysiology is related to inflammatory pathway and strategies that modulate this are potentially useful. The Pirfenidone (PDF) is an anti-fibrotic and anti-inflammatory treatment, in animal models has shown a beneficial effect on the recovery of renal function immediately after administrated. The investigators propose a triple blind clinical trial,in which septic AKI patients will be randomized in three arms, all receive conventional treatment KDIGO guides, groupPDF 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days. The Investigators analyze the recovery of renal function as a primary objective, as a secondary objectives clinical variables associated with renal recovery, biochemical variables, inflammatory, molecular variables and measurement of PDF in blood will be analyzed. Patients will be follow-up for 7 days and 28 days after randomization.
Interventions
Placebo equivalent per mouth
Pirfenidone extended release 600mg per mouth
Sponsors
Study design
Eligibility
Inclusion criteria
. sepsis * AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine \<2 mg / dL)
Exclusion criteria
* Chronic kidney disease stage 3b, 4 or 5 (basal serum creatinine \> 2mg/dl) known and / or sharpened. * chronic dialysis (peritoneal dialysis or hemodialysis) * History of AKI and / or RRT in the last three months * Pregnancy AKI by other causes other than sepsis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| renal function recovery | within the first 7 days | serum creatinine in serum \<2mg/dl and urinary output \>1,200 ml/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-1 | on day 1 and day 7 | Interleucin 1 in serum pg/mL |
| IL-6 | on day 1 and day 7 | Interleucin 6 in serum pg/mL |
| TNF-α | on day 1 and day 7 | tumor necrosis factor in serum pg/dL |
| Toll-like receptor 4 | on day 1 and day 7 | Toll-like receptor 4 in serum pg/dL |
| pirfenidone levels in serum ug/mL | on day 1 and day 7 | pirfenidone levels in serum ug/mL |
| need of renal replacement therapy (RRT) | within the first 7 days | the patient still need renal replacement (RRT) by the judgment of the nephrologist. |
| mortality | within the first 7 days | the patient dead |
| serum creatinine levels | within the first 7 days | serum creatinine levels in mg/dL |
| serum urea levels | within the first 7 days | serum urea levels in mg/dL |
| Urinary Volume | within the first 7 days | Urinary Volume in milliliters in 24 hours |