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

NCT02587078 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-11-30

No results posted yet for this study

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®

Conditions

  • Severe Sepsis

Interventions

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.

Sponsors & Collaborators

  • Wuerzburg University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-06-30
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587078 on ClinicalTrials.gov