title: Fluid loading in abdominal surgery - saline versus hydroxyethyl starch (FLASH Trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Inappropriate fluid therapy during surgery is associated with significant morbidity and mortality. Few studies have examined the effects of particular types of fluids (crystalloid or colloid solutions) in surgical patients, especially with the goal of hemodynamic optimization. Isotonic saline is the most commonly used fluid worldwide but may be associated with potential nephrotoxicity. Hydroxyethyl starch (HES) solutions are widely used in surgical patients as a component of goal-directed fluid optimization strategies, but several large multicenter studies have suggested increased rates of acute kidney injury and adverse events with the use of HES in ICU patients. Despite what may be inferred from physiological studies, the benefit and harm of 0.9 % saline and HES during hemodynamic therapy have not been clearly established in surgical patients.
  
  
  METHODS
  The FLASH trial is an investigator-initiated, prospective, multicenter, randomized, double-blinded, two-arm trial, randomizing 826 patients with moderate-to-high risk of postoperative complications to receive 6 % HES 130/0.4 or 0.9 % saline during individualized goal-directed fluid optimization. The primary outcome measure is a composite of death or major postoperative complications within 14 days following surgery. The sample size will allow the detection of a 10 % absolute between-group difference in the primary outcome measure with a type 1 error rate of 5 % and power of 95 %, assuming a 5 % mortality rate and 20 % morbidity (thus 25 % for the composite endpoint).
  
  
  CONCLUSIONS
  The FLASH trial may provide important data on the efficacy and safety of commonly used fluid solutions and could have a significant impact on future treatment of surgical patients.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02502773 . Registered 16 June 2015.
authors.affiliation: CHU de Clermont-Ferrand, Département Anesthésie et Réanimation, Pôle Médecine Périopératoire (MPO), Hôpital Estaing, 1 place Lucie Aubrac, 63001, Clermont-Ferrand cedex 1, France. efutier@chu-clermontferrand.fr.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Futier
authors.affiliation: CHU de Bordeaux, Service Anesthésie et Réanimation III, Unité de Neuro-Réanimation, Hôpital Pellegrin, Tripode, Bordeaux, F-33076, France. matthieu.biais@chu-bordeaux.fr.
authors.forename: Matthieu
authors.initials: M
authors.lastname: Biais
authors.affiliation: CHU de Clermont-Ferrand, Département Anesthésie et Réanimation, Pôle Médecine Périopératoire (MPO), Hôpital Estaing, 1 place Lucie Aubrac, 63001, Clermont-Ferrand cedex 1, France. tgodet@chu-clermontferrand.fr.
authors.forename: Thomas
authors.initials: T
authors.lastname: Godet
authors.affiliation: CHU de Clermont-Ferrand, Pôle Pharmacie, et EA 467 C-BIOSENSS, BP 10448, Clermont-Ferrand, F-63003, France. l_bernard@chu-clermontferrand.fr.
authors.forename: Lise
authors.initials: L
authors.lastname: Bernard
authors.affiliation: CHU de Clermont-Ferrand, Direction de la Recherche Clinique (DRCI), Clermont-Ferrand, F-63003, France. crolhion@chu-clermontferrand.fr.
authors.forename: Christine
authors.initials: C
authors.lastname: Rolhion
authors.affiliation: CHU de Clermont-Ferrand, Direction de la Recherche Clinique (DRCI), Clermont-Ferrand, F-63003, France. jbourdier@chu-clermontferrand.fr.
authors.forename: Justine
authors.initials: J
authors.lastname: Bourdier
authors.affiliation: CHU de Clermont-Ferrand, Direction de la Recherche Clinique (DRCI), Clermont-Ferrand, F-63003, France. dmorand@chu-clermontferrand.fr.
authors.forename: Dominique
authors.initials: D
authors.lastname: Morand
authors.affiliation: CHU de Clermont-Ferrand, Biostatistics unit, Direction de la Recherche Clinique (DRCI), Clermont-Ferrand, F-63003, France. bpereira@chu-clermontferrand.fr.
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.affiliation: CHU de Montpellier, Département Anesthésie et Réanimation B (DAR B), Hôpital Saint-Eloi, et INSERM U-1046, Montpellier, F-34295, France. s-jaber@chu-montpellier.fr.
authors.forename: Samir
authors.initials: S
authors.lastname: Jaber
mesh_terms: D000005:Abdomen / Q000601:surgery*; D002985:Clinical Protocols; D004311:Double-Blind Method; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D005602:France; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage* / Q000009:adverse effects; D007813:Laparotomy / Q000009:adverse effects / Q000401:mortality; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D012107:Research Design; D012965:Sodium Chloride / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D012965:Sodium Chloride