NCT02587078

Volume Therapy With Crystalloids and Colloids and Hemodynamic Monitoring in Patients With Severe Sepsis

Volume Therapy With Crystalloids and Colloids

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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®

Detailed description

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)

Conditions

• Severe Sepsis

Interventions

Type	Name	Description
DRUG	Volulyte	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.
DRUG	Jonosteril	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2015-10-27
• Last updated: 2016-11-30