This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
167
Gelaspan combined with Sterofundin ISO
Sterofundin ISO
Medizinische Universität Innsbruck
Innsbruck, Austria
Masarykova nemocnice v Ústí nad Labem, o.z.
Ústí nad Labem, Czechia
Université de Nantes
Nantes, France
Time Until First/Initial Hemodynamic Stabilization
Time from first administration of IMP to first achievement of confirmed hemodynamic stability
Time frame: 48 hours after treatment start
Length of Stay (LOS) in the Intensive Care Unit (ICU)
Length of stay (LOS) in the intensive care unit (ICU)= Date of ICU discharge - date of ICU admission + 1
Time frame: Intensive care unit (ICU) discharge or day 28
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Hôpital Pasteur 2 - CHU de Nice
Nice, France
Universitätsklinikum Aachen
Aachen, Germany
Klinikum Bremen-Mitte
Bremen, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Universitätsinstitut - Johannes Wesling Klinikum Minden
Minden, Germany
Universitätsmedizin Rostock
Rostock, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
...and 2 more locations