title: [Study protocol of the VISEP study. Response of the SepNet study group].
abstract: In the commentary by Zander et al. the authors appear concerned about the methods and results of our, at that time, unpublished sepsis trial evaluating hydroxyethyl starch (HES) and insulin therapy. Unfortunately, the authors' concerns are based on false assumptions about the design, conduct and modes of action of the compounds under investigation. For instance, in our study the HES solution was not used for maintenance of daily fluid requirements, so that the assumption of the authors that this colloid was used "exclusively" is wrong. Moreover, the manufacturer of Hemohes, the HES product we used, gives no cut-off value for creatinine, thus the assumption that this cut-off value was "doubled" in our study is also incorrect. Other claims by the authors such as that lactated solutions cause elevated lactate levels, iatrogenic hyperglycemia and increase O(2) consumption are unfounded. There is no randomized controlled trial supporting such a claim - this claim is neither consistent with our study data nor with any credible published sepsis guidelines or with routine practice worldwide. We fully support open scientific debate. Our study methods and results have now been published after a strict peer-reviewing process and this data is now open to critical and constructive reviewing. However, in our opinion this premature action based on wrong assumptions and containing comments by representatives of pharmaceutical companies does not contribute to a serious, unbiased scientific discourse.
authors.forename: K
authors.initials: K
authors.lastname: Reinhart
authors.forename: F M
authors.initials: FM
authors.lastname: Brunkhorst
authors.forename: C
authors.initials: C
authors.lastname: Engel
authors.forename: F
authors.initials: F
authors.lastname: Bloos
authors.forename: A
authors.initials: A
authors.lastname: Meier-Hellmann
authors.forename: M
authors.initials: M
authors.lastname: Ragaller
authors.forename: N
authors.initials: N
authors.lastname: Weiler
authors.forename: O
authors.initials: O
authors.lastname: Moerer
authors.forename: M
authors.initials: M
authors.lastname: Gruendling
authors.forename: M
authors.initials: M
authors.lastname: Oppert
authors.forename: S
authors.initials: S
authors.lastname: Grond
authors.forename: D
authors.initials: D
authors.lastname: Olthoff
authors.forename: U
authors.initials: U
authors.lastname: Jaschinski
authors.forename: S
authors.initials: S
authors.lastname: John
authors.forename: R
authors.initials: R
authors.lastname: Rossaint
authors.forename: T
authors.initials: T
authors.lastname: Welte
authors.forename: M
authors.initials: M
authors.lastname: Schaefer
authors.forename: P
authors.initials: P
authors.lastname: Kern
authors.forename: E
authors.initials: E
authors.lastname: Kuhnt
authors.forename: M
authors.initials: M
authors.lastname: Kiehntopf
authors.forename: T
authors.initials: T
authors.lastname: Deufel
authors.forename: C
authors.initials: C
authors.lastname: Hartog
authors.forename: H
authors.initials: H
authors.lastname: Gerlach
authors.forename: F
authors.initials: F
authors.lastname: Stüber
authors.forename: H-D
authors.initials: HD
authors.lastname: Volk
authors.forename: M
authors.initials: M
authors.lastname: Quintel
authors.forename: M
authors.initials: M
authors.lastname: Loeffler
mesh_terms: D001810:Blood Volume / Q000187:drug effects / Q000502:physiology; D003102:Colloids / Q000627:therapeutic use; D003422:Critical Care / Q000592:standards; D000077324:Crystalloid Solutions; D023381:Endpoint Determination; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D007552:Isotonic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D010952:Plasma Substitutes / Q000008:administration & dosage / Q000627:therapeutic use*; D012107:Research Design; D018805:Sepsis / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D003102:Colloids; D000077324:Crystalloid Solutions; D007004:Hypoglycemic Agents; D007328:Insulin; D007552:Isotonic Solutions; D010952:Plasma Substitutes