Clinical trial
Impact of CVVHD With Increased Adsorption Membranes in Septic Acute Kidney Injury
Severe septic patients with acute kidney injury (AKI) requiring continuous renal replacement therapies (CRRT) present high mortality due to systemic inflammatory response, cytokine liberation, and finally multiorgan dysfunction. Cytokine plasmatic elimination with continuous venovenous hemofiltration (CVVH) presents frequent complications, known as "dialytrauma", and a high resource cost both technical and human. The study primary end-point is to demonstrate a non-inferiority survival of continuous venovenous hemodialysis (CVVHD) plus an adsorption membrane respect to CVVH plus an adsorption membrane. As secondary end-points investigators will try to demonstrate immunomodulation and technical superiority of CVVHD respect to CVVH. In order to achieve these objectives investigators have designed a randomized controlled trial that will include those patients whom present severe sepsis and AKI meeting CRRT initiation criteria. During the first 72 hours investigators will measure plasmatic elimination capacity of main cytokines, lipopolysaccharide (LPS), and other clinical and prognostic relevant molecules. Investigators will also measure hemodynamic, respiratory, and metabolic parameters. Adverse effects related to CRRT ("dialytrauma") will also be registrated. Finally, investigators will analyze 90 days survival. Demonstration of a non inferiority survival added to a superior immunomodulating capacity and a minor complication rate with its consequent lower cost, should settle the based evidence principles that recommend the use of CVVHD asociated to an adsorption membrane in severe septic patients with AKI whom need CRRT.
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Study start date | 2013-02-08 |