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BERTRAND Pierre-Marie Clermont Ferrand

BERTRAND Pierre-Marie Clermont Ferrand. Article original Etude épidémiologique, prospective, multicentrique, contrôlé, randomisé, sans aveugle ClinicalTrial.gov :

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BERTRAND Pierre-Marie Clermont Ferrand

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  1. BERTRAND Pierre-Marie Clermont Ferrand

  2. 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 […]

  3. 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

  4. 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)

  5. Matériel et Méthode

  6. Flowchart

  7. Résultats

  8. Discussion

  9. Inclusion/Exclusion

  10. ? 2 bras « hétérogènes » HDI /j = HFC 35mL/kg/j = SLED /j ≠ HDI /2j = HFC 20mL/kg/j = SLED /2j

  11. Protocole Complexe

  12. HFC Intensive Less Intensive

  13. HDI Intensive Less Intensive = 7,8/sem = 3,9/sem

  14. Complications

  15. Contrôle de la Volémie Intensive Less Intensive

  16. Biais minimum dead

  17. 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)

  18. En Conclusion

  19. Réponse à la question • L’étude apporte une réponse à la question posée. • La question modérément pertinente • L’étude ne permet pas de conclure

  20. Conséquence • Je ne modifie pas ma pratique quotidienne

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