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 protocolReportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 15:270

First Online: 07 July 2014Received: 27 January 2014Accepted: 26 June 2014DOI: 10.1186-1745-6215-15-270

Cite this article as: Barbar, S.D., Binquet, C., Monchi, M. et al. Trials 2014 15: 270. doi:10.1186-1745-6215-15-270

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.

Keywordssevere acute kidney injury septic shock renal replacement therapy intensive care AbbreviationsADQIAcute Dialysis Quality Initiative

AKIacute kidney injury

AKINAcute Kidney Injury Network

CIC-ECCentre for Clinical Investigation and Clinical Epidemiology of the University Hospital of Dijon, France

CRFcase report form

EQ-5DEuropean Quality of Life Five Dimensions questionnaire

ICUintensive care unit

ITTintention to treat

KDIGOKidney Disease: Improving Global Outcomes

MDRDmodification of diet in renal disease

RIFLErisk, injury, failure, loss, end-stage kidney disease

RRTrenal replacement therapy

SAPS IIsimplified acute physiology score

SLEDsustained low-efficiency dialysis

SOFAsequential organ failure assessment

VASvisual analogue scale.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-270 contains supplementary material, which is available to authorized users.

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Autor: Saber Davide Barbar - Christine Binquet - Mehran Monchi - Rémi Bruyère - Jean-Pierre Quenot

Fuente: https://link.springer.com/







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