title: Influence of a long-term, high-dose volume therapy with 6% hydroxyethyl starch 130/0.4 or crystalloid solution on hemodynamics, rheology and hemostasis in patients with acute ischemic stroke. Results of a randomized, placebo-controlled, double-blind study.
abstract: BACKGROUND
  This study was performed to investigate the clinical effects of a 4-day volume therapy with a newly developed, 6% hydroxyethyl starch (HES) 130/0.4 versus crystalloid solution, with particular regard to systemic and cerebral hemodynamics, rheology and safety.
  
  
  METHODS
  In a randomized, double-blind study, 40 patients suffering from an acute ischemic stroke received either 6% HES 130/0.4 or crystalloid solution as continuous infusion over 4 days with a total dose of 6.5 liters. Efficacy parameters studied included hemodynamics (cardiac output, blood pressure, flow velocity with transcranial Doppler) and rheology (hematocrit and plasma viscosity). Safety parameters examined included laboratory, hemostaseology (including factor VIII) and an adverse event questionnaire (including pruritus).
  
  
  RESULTS
  In both groups, a small, but not significant increase in cardiac output was observed. There were no significant changes regarding the remaining efficacy or safety parameters, except for the well-known increase in serum alpha-amylase through the infusion of HES.
  
  
  CONCLUSIONS
  In our study with patients suffering from acute ischemic stroke, continuous infusion (1 ml/min) of HES 130/0.4 or crystalloid solution did not differ regarding safety or hemodynamic efficacy.
authors.affiliation: Department of Neurology, Westpfalz Klinikum, University City of Kaiserslautern, Kaiserslautern, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Woessner
authors.forename: Markus T
authors.initials: MT
authors.lastname: Grauer
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Dieterich
authors.forename: Frank
authors.initials: F
authors.lastname: Bepperling
authors.forename: Daniela
authors.initials: D
authors.lastname: Baus
authors.forename: Timo
authors.initials: T
authors.lastname: Kahles
authors.forename: Sven
authors.initials: S
authors.lastname: Georgi
authors.forename: Oliver
authors.initials: O
authors.lastname: Bianchi
authors.forename: Martin
authors.initials: M
authors.lastname: Morgenthaler
authors.forename: Johannes
authors.initials: J
authors.lastname: Treib
mesh_terms: D002545:Brain Ischemia / Q000097:blood / Q000188:drug therapy; D002302:Cardiac Output / Q000187:drug effects; D000077324:Crystalloid Solutions; D004311:Double-Blind Method; D006439:Hemodynamics / Q000187:drug effects*; D018056:Hemorheology / Q000187:drug effects; D006487:Hemostasis / Q000187:drug effects*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage* / Q000633:toxicity; D007552:Isotonic Solutions; D010952:Plasma Substitutes / Q000008:administration & dosage* / Q000633:toxicity; D020521:Stroke / Q000097:blood / Q000188:drug therapy*; D013810:Therapeutic Equivalency; D013997:Time Factors
chemical_list: D000077324:Crystalloid Solutions; D006895:Hydroxyethyl Starch Derivatives; D007552:Isotonic Solutions; D010952:Plasma Substitutes