The primary alternative hypothesis is that less time (minutes) is required, to achieve the initial hemodynamic stabilization, with Volulyte® compared to Jonosteril®. * H01: Minutes with Volulyte® ≥ Minutes with Jonosteril® * H11: Minutes with Volulyte® \< Minutes with Jonosteril®
Comparative, multicenter, active-controlled, parallel-group, double-blind, randomized study. Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either receive intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. Assessment of the effects of fluid resuscitation to achieve the primary and secondary endpoints will be performed up to 24 hours following the randomization. Initial hemodynamic stabilization is defined as normalization of mean arterial pressure (MAP), central venous oxygen saturation (ScvO2) and PPV (pulse pressure variation) or response to PLR (passive leg rising) as defined below and maintaining this normalization over a period of 1 hour, with no increase in the infusion of vasopressors, or inotropic therapy and with ≤ 250ml of additional study drug administration within this 1 hour. The normalization of the parameters MAP and PPV (pulse pressure variation) or PLR (passive leg rising) and ScvO2 is defined as follows: * MAP: ≥ 65 mmHg * ScvO2: ≥ 70% * PPV: ≤ 12% (premise: sinus rhythm, no spontaneous breathing efforts and mechanical ventilation with VT: 5 - \< 6 ml/kg). If PPV is not applicable, response to PLR-manoeuvre is used (see below). ● PLR: \< 10% change in cardiac output (CO)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization.
Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization.
The primary endpoint is defined as the fraction of patients who achieved initial hemodynamic stabilization during the first 6 hours after randomisation.
Time frame: During the first 6 hours
Time needed for achievement of initial hemodynamic stabilization during the first 24 hours after randomization.
Time frame: during the first 24 hours after randomization.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.