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Open Access Highly Accessed Study protocol

Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial

Saber Davide Barbar1*, Christine Binquet2, Mehran Monchi3, Rémi Bruyère4 and Jean-Pierre Quenot4

Author Affiliations

1 Service de Réanimation Médicale, CHU de Nîmes – Hôpital Carémeau, Nîmes, France

2 INSERM, CIE1, CHU Dijon, Centre d’Investigation Clinique –Epidémiologie Clinique (CIC-EC), Dijon, France

3 Service de Réanimation Polyvalente, CH de Melun, Melun, France

4 Service de Réanimation Médicale, CHU Le Bocage, & INSERM UMR866, Faculty of Medicine, Dijon, France

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Trials 2014, 15:270  doi:10.1186/1745-6215-15-270

Published: 7 July 2014

Abstract

Background

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. 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/design

This 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.

Discussion

This 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 registration

ClinicalTrials.gov identifier NCT01682590, registered on 10 September 2012.

Keywords:
severe acute kidney injury; septic shock; renal replacement therapy; intensive care