bertrand pierre-marie clermont ferrand
DESCRIPTION
BERTRAND Pierre-Marie Clermont Ferrand. Article original Etude épidémiologique, prospective, multicentrique, contrôlé, randomisé, sans aveugle ClinicalTrial.gov : - PowerPoint PPT PresentationTRANSCRIPT
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BERTRAND Pierre-Marie
Clermont Ferrand
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• Article original– Etude épidémiologique, prospective,
multicentrique, contrôlé, randomisé, sans aveugle• ClinicalTrial.gov :
– Primary Hypothesis: An intensive management strategy for renal support in critically ill patients with acute renal failure decreases mortality as compared to less intensive (conventionally recommended) management strategies for renal replacement therapy.
– Secondary Hypotheses: An intensive management strategy for renal support in critically ill patients with acute renal failure will shorten the duration of ARF, decrease the incidence and duration of non-renal complications and is cost-effective as compared to less intensive (conventionally recommended) management strategies for renal replacement therapy.Critère principal :
[…] intensive management strategy for renal
support in critically ill patients with acute
renal failure decreases mortality […]
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• Critère Principal– Mortalité toute cause à J60
• Critères secondaires : – Mortalité Hospitalière– Récup. fct° rénale (ClCr > 20mL/min)– Durée d’EER– Durée séjour en Réa– Jours sans dysfonction d’organe– Retours à domicile sans HDI
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Statistiques
• Nombre de patients à inclure : – 1164 pour– α = 0,05 bilatéral; 1-β = 0,9; 10% de différence– Analyses intermédiaires prévus adaptées (Haybittle and
Peto)
• Mortalité à J+60– Régression logistique par strate (oligurie, sexe, SOFA CV,
sepsis)– Kaplan–Meier
• Critère secondaire– Analyse de Variance (ANOVA)
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Matériel et Méthode
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Flowchart
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Résultats
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Discussion
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Inclusion/Exclusion
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2 bras « hétérogènes »
HDI /j = HFC 35mL/kg/j = SLED /j
≠
HDI /2j = HFC 20mL/kg/j = SLED /2j?
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Protocole Complexe
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HFCIntensive Less Intensive
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HDIIntensive Less Intensive
= 3,9/sem
= 7,8/sem
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Complications
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Contrôle de la Volémie
Intensive Less Intensive
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Biais minimum
dead
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Validité externe
• Hypothèse physiologique– Pertiente
• Cohérence avec la littérature– Schiffl, NEJM 02 (HDI /j)– Pannu, JAMA 08 (HDI = HFC 35 mL/kg/j)– Tonelli, AJKD 02 (HDI = HFC )– Bouman, Crit Care Med (Early vs. low vs.
hight volume HFC)– Ronco, Lancet 00 (20 vs. 35 vs. 40 mL/kg/h)
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En Conclusion
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Réponse à la question
• L’étude apporte une réponse à la question posée.
• La question modérément pertinente
• L’étude ne permet pas de conclure
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Conséquence
• Je ne modifie pas ma pratique quotidienne