Canadian Journal of Anesthesia

, Volume 55, Issue 12, pp 819–826

Fluid resuscitation in the management of early septic shock (FINESS): a randomized controlled feasibility trial

  • Lauralyn A. McIntyre
  • Dean Fergusson
  • Deborah J. Cook
  • Nigel Rankin
  • Vinay Dhingra
  • John Granton
  • Sheldon Magder
  • Ian Stiell
  • Monica Taljaard
  • Paul C. Hebert
  • the Canadian Critical Care Trials Group
Reports Of Original Investigations

Abstract

Background: It is unknown whether fluid resuscitation with colloid or crystalloid in patients with severe sepsis or septic shock is associated with an improvement in clinical outcome. This randomized controlled trial determined the feasibility of conducting a large trial testing resuscitation with pentastarchvs normal saline in early septic shock, powered for a difference in mortality.

Methods: At three Canadian and one New Zealand academic centre, 40 patients with early septic shock defined by at least two systemic inflammatory response syndrome criteria, infectious source, and persistent hypotension after ≥ 1 L of crystalloid fluid were recruited. Feasibility measures were patient recruitment, blinding of the study fluids, and acceptability of the goal directed algorithms. Boluses of blinded normal saline or pentastarch (500 mL − maximum 3 L or 28 mL·kg−1) were administered within goal directed care for the first 12 hr.

Results: Of 161 patients screened, 121 were excluded and 40 patients were enrolled, for a recruitment rate of 0.75 patients/ site/month. Only 57% of physicians and 54% of nurses correctly guessed the study fluid (P = 0.46 andP = 0.67, respectively). The goal directed algorithms were acceptable to 97% of physicians.

Conclusion: The ability to recruit patients in this pilot randomized controlled trial was below expectations. Blinding of study fluids was adequate, and resuscitation algorithms were acceptable to most physicians. Methods to improve recruitment are required to enhance the feasibility of conducting a multicentre fluid resuscitation trial in early septic shock.

La réanimation liquidienne dans la prise en charge du début du choc septique (FINESS) : une étude randomisee contrôlée de faisabilité

Résumé

Contexte: Nous ne savons pas si la réanimation liquidienne avec des colloïdes ou des cristalloïdes chez les patients présentant un sepsis grave ou un choc septique est associée à un devenir clinique meilleur. Cette étude randomisée contrôlée a déterminé la faisabilité d’une étude d’envergure testant la réanimation avec le pentastarch par rapport au sérum physiologique en début de choc septique, avec pour objectif primaire de détecter une différence dans les taux de mortalité.

Methode: Quarante patients en début de choc septique, défini comme au moins deux critères du syndrome de réaction inflammatoire, une source d’infection et une hypotension persistante après ≥ 1 L de cristalloïde ont été recrutés dans trois centres universitaires canadiens et un centre néo-zélandais. Les mesures de faisabilite étaient: le recrutement des patients, le masquage des liquides à l’étude, et I’acceptabilité des algorithmes dirigés vers des objectifs. Des bolus de normal sal in ou de pentastarch (500 mL — maximum 3 L ou 28 mL·kg−1) ont été administrés en aveugle dans le cadre de soins guidés dirigés vers des objectifs durant les 12 premieres heures.

Resultats: Sur 161 patients dépistés, 121 ont été exclus et 40 patients recrutés dans le cadre de I’étude, avec un taux de recrutement de 0,75 patient/site/mois. Seulement 57 % des médecins et 54 % des infirmières ont réussi à deviner correctement le type de liquide à I’étude (P = 0,46 etP = 0,67, respectivement). Les algorithmes ont été jugés acceptables par 97 % des médecins.

Conclusion: La capacité à recruter des patients pour cette étude pilote randomisée contrôlée était moins importante qu’attendue. Le masquage des liquides était satisfaisant, et les algorithmes de réanimation ont été jugés acceptables par la majorité des médecins. Des méthodes dans le but d’améliorer le recrutement sont nécessaire pour accroître la faisabilité d’une étude multicentrique sur la réanimation liquidienne en début de choc septique.

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Copyright information

© Canadian Anesthesiologists 2008

Authors and Affiliations

  • Lauralyn A. McIntyre
    • 1
  • Dean Fergusson
    • 2
  • Deborah J. Cook
    • 3
  • Nigel Rankin
    • 4
  • Vinay Dhingra
    • 5
  • John Granton
    • 6
  • Sheldon Magder
    • 7
  • Ian Stiell
    • 8
  • Monica Taljaard
    • 2
  • Paul C. Hebert
    • 1
  • the Canadian Critical Care Trials Group
  1. 1.Clinical Epidemiology Unit of the Ottawa HospitalFrom the University of Ottawa Centre for Transfusion and Critical Care ResearchOttawaCanada
  2. 2.Clinical Epidemiology Program of the Ottawa HospitalOttawa Health Research InstituteOttawaCanada
  3. 3.the Clarity Research Group, Department of Medicine and Clinical Epidemiology & Biostatis-ticsMcMaster University Health Sciences CentreHamiltonCanada
  4. 4.the Middlemore HospitalAucklandNew Zealand
  5. 5.the Vancouver General HospitalVancouverCanada
  6. 6.the University Health Network, University of TorontoTorontoCanada
  7. 7.the Royal Victoria HospitalMontrealCanada
  8. 8.the Emergency Medicine, Ottawa Health Research InstituteUniversity of OttawaOttawaCanada

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