title: Quality of life and pruritus in patients with severe sepsis resuscitated with hydroxyethyl starch long-term follow-up of a randomised trial.
abstract: BACKGROUND
  The effects of hydroxyethyl starch (HES) on patient-centered outcome measures have not been fully described in patients with severe sepsis. We assessed health-related quality of life (HRQoL) and the occurrence of pruritus in patients with severe sepsis randomized to resuscitation with HES 130/0.42 or Ringer's acetate.
  
  
  METHODS
  We did post hoc analyses of the Danish survivors (n=295) of the 6S trial using mailed questionnaires on self-perceived HRQoL (Short Form (SF) - 36) and pruritus.
  
  
  RESULTS
  Median 14 months (interquartile range 10 to 18) after randomization, 182 (61%) and 185 (62%) completed questionnaires were obtained for the assessment of HRQoL and pruritus, respectively. Responders were older than nonresponders, but characteristics at randomization of the responders in the HES vs. Ringer's groups were comparable. At follow-up, the patients in the HES group had lower mental component summary scores than those in the Ringer's group (median 45 (interquartile range 36 to 55) vs. 53 (39 to 60), P=0.01). The group differences were mainly in the scales of vitality and mental health. There was no difference in the physical component summary scores between groups, but patients in the HES group scored worse in bodily pain. Forty-nine percent of patients allocated to HES had experienced pruritus at any time after ICU discharge compared to 43% of those allocated to Ringer's (relative risk 1.13, 95% confidence interval 0.83 to 1.55, P=0.43).
  
  
  CONCLUSIONS
  At long-term follow-up patients with severe sepsis assigned to resuscitation with HES 130/0.42 had worse self-perceived HRQoL than those assigned to Ringer's acetate whereas there were no statistically significant differences in the occurrence of pruritus.
authors.forename: Piotr
authors.initials: P
authors.lastname: Wittbrodt
authors.forename: Nicolai
authors.initials: N
authors.lastname: Haase
authors.forename: Dominika
authors.initials: D
authors.lastname: Butowska
authors.forename: Robert
authors.initials: R
authors.lastname: Winding
authors.forename: Jesper B
authors.initials: JB
authors.lastname: Poulsen
authors.forename: Anders
authors.initials: A
authors.lastname: Perner
mesh_terms: D000368:Aged; D005260:Female; D005440:Fluid Therapy / Q000639:trends; D005500:Follow-Up Studies; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage*; D007552:Isotonic Solutions / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011537:Pruritus / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D012151:Resuscitation / Q000639:trends; D018805:Sepsis / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D016037:Single-Blind Method; D013997:Time Factors
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D007552:Isotonic Solutions; C028570:Ringer's acetate