Quality of life and pruritus in patients with severe sepsis resuscitated with hydroxyethyl starch long-term follow-up of a randomised trial

Abstract

IntroductionThe 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.MethodsWe 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.ResultsMedian 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).ConclusionsAt 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.

Factors associated with non‐response at health‐related quality of life follow‐up in a septic shock trial

“…The only covariate that differed between non‐responders and responders at the time of randomization was age. In several HRQoL follow‐up studies of former ICU survivors, the non‐responders have been found to be younger than the responders . But in HRQoL surveys of the general population the opposite has been observed; the non‐responder were older .…”

“…Clinical trials have reported lower age to be associated with non‐response in HRQoL surveys in ICU patients, and increased morbidity has also been hypothesized to reduce response rates . Not responding HRQoL among ICU survivors in general is described with higher frequency of delirium, and associated with female gender, higher sickness score, less hours in ICU and less hours on ventilator …”

The crystalloid‐colloid debate: Consequences of resuscitation fluid selection in veterinary critical care

“…For example, tissue uptake in small peripheral nerves and skin is implicated in HES‐associated pruritus and has a reported incidence ranging from 30% to 60% in HES‐treated human patients . HES‐induced pruritus has a delayed onset (typically 1–6 weeks postexposure), is refractory to available therapies, and can last up to 24 months . Current data have failed to support previous hypotheses that newer generation lower MW HES solutions will have reduced tissue uptake and expedited renal excretion.…”

Use of infusion solutions in critically ill: Literature review

“…Ograničenje upotrebe dobija na snazi sa pojavom ESCIM (European Society of Intensive Care Medicine) preporuka 43 da produkte koji sadrže HES ne treba koristiti kod septičnih pacijenata (1B), drugih kritično obolelih pacijenata sa rizikom od akutnog bubrežnog ošte-ćenja (1C) ili kod pacijenata sa povredama glave i intrakranijalnim krvarenjem (1C). Ako se uzmu u obzir i rezultati jednogodišnje post hoc analize, 6S studije 44 u kojoj su pacijenti iz HES grupe imali lošiji kvalitet života u poređenju sa pacijentima iz Ringer--acetat grupe, može se smatrati da HES nije doneo poboljšanje pacijentima sa teškom sepsom.…”