Severe Sepsis Clinical Trial
Official title:
Volume Therapy With Crystalloids and Colloids
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)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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