The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.
Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids. In critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Universitätsklinikum der RWTH Aachen
Aachen, Germany
Klinikum Augsburg
Augsburg, Germany
VIVANTES Klinikum Neukölln II
Berlin, Germany
Mortality (28 day)
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
Frequency of acute kidney failure
Time until hemodynamic stabilization
Frequency of therapy with vasopressors (in days)
Course of SOFA sub-scores
Frequency of hemorrhages under hydroxyethyl starch (HES) therapy
Frequency of hypoglycemia under intensive insulin therapy
Frequency of critical illness polyneuropathy (CIP)
90 day Mortality
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Charité I Campus Virchow-Klinikum
Berlin, Germany
Städtisches Klinikum Brandenburg GmbH
Brandenburg, Germany
Krankenhaus Dresden Friedrichstadt
Dresden, Germany
Universität Carl-Gustav-Carus
Dresden, Germany
HELIOS Klinikum Erfurt
Erfurt, Germany
Universität Erlangen-Nürnberg
Erlangen, Germany
Georg-August-Universität Göttingen
Göttingen, Germany
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