Abstract
BackgroundOne of the most dreaded complications of septic shock is acute kidney injury. It occurs in around 50% of patients, with a mortality rate of about 60% at 3 months. There is no consensus on the optimal time to initiate renal replacement therapy. Retrospective and observational studies suggest that early implementation of renal replacement therapy could improve the prognosis for these patients.Methods/designThis protocol summarizes the rationale and design of a randomized, controlled, multicenter trial investigating the effect of early versus delayed renal replacement therapy in patients with severe acute kidney injury in early septic shock. In total, 864 critically ill adults with septic shock and evidence of acute kidney injury, defined as the failure stage of the RIFLE classification, will be enrolled. The primary outcome is mortality at 90 days. Secondary outcomes include safety, number of days free of mechanical ventilation, number of days free of renal replacement therapy, intensive care length of stay, in-hospital length of stay, quality of life as evaluated by the EQ-5D and renal replacement therapy dependence at hospital discharge. The primary analysis will be intention to treat. Recruitment started in March 2012 and will be completed by March 2015.DiscussionThis protocol for a randomized controlled study investigating the impact of the timing of renal replacement therapy initiation should provide an answer to a key question for the management of patients with acute kidney injury in the context of septic shock, for whom the mortality rate remains close to 60% despite improved understanding of physiopathology and recent therapeutic advances.Trial registrationClinicalTrials.gov identifier NCT01682590, registered on 10 September 2012.
Highlights
One of the most dreaded complications of septic shock is acute kidney injury
We propose a randomized, multicenter, controlled trial on the impact on mortality of the timing of renal replacement therapy (RRT) initiation in patients with acute kidney failure in septic shock
The primary objective is to assess whether the timing of RRT initiation has an impact on mortality at 90 days in patients with acute kidney injury (AKI) at the failure stage according to the RIFLE criteria [23], during the initial phase of septic shock
Summary
One of the most dreaded complications of septic shock is acute kidney injury. It occurs in around 50% of patients, with a mortality rate of about 60% at 3 months. Retrospective and observational studies suggest that early implementation of renal replacement therapy could improve the prognosis for these patients. The incidence of acute kidney injury (AKI) in patients with septic shock is around 50% [1,2,3]. The need for renal replacement therapy (RRT) contributes to increasing the risk of death from less than 40% in septic shock without AKI, to over 60% in the forms associated with severe AKI requiring RRT [4].
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