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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Pirfenidone extended release 600mg per mouth
Placebo equivalent per mouth
renal function recovery
serum creatinine in serum \<2mg/dl and urinary output \>1,200 ml/day
Time frame: within the first 7 days
renal function recovery
serum creatinine in serum \<2mg/dl and urinary output \>1,200ml/day
Time frame: within the first 28 days
Urinary Volume
Urinary Volume in milliliters in 24 hours
Time frame: within the first 7 days
need of renal replacement therapy (RRT)
the patient still need renal replacement (RRT) by the judgment of the nephrologist.
Time frame: within the first 7 days
mortality
the patient dead
Time frame: within the first 7 days
serum creatinine levels
serum creatinine levels in mg/dL
Time frame: within the first 7 days
serum urea levels
serum urea levels in mg/dL
Time frame: within the first 7 days
pirfenidone levels in serum ug/mL
pirfenidone levels in serum ug/mL
Time frame: on day 1 and day 7
IL-1
Interleucin 1 in serum pg/mL
Time frame: on day 1 and day 7
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IL-6
Interleucin 6 in serum pg/mL
Time frame: on day 1 and day 7
TNF-α
tumor necrosis factor in serum pg/dL
Time frame: on day 1 and day 7
Toll-like receptor 4
Toll-like receptor 4 in serum pg/dL
Time frame: on day 1 and day 7