NCT00464204

Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	6 % Hydroxyethylstarch 130/0.4 = "Voluven®"	Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs.
DRUG	0.9 % NaCl	NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day, according to patient needs.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-05-01
• Completion: 2010-12-01
• First posted: 2007-04-23
• Last updated: 2012-01-11
• Results posted: 2011-08-02

Locations

24 sites across 2 countries: France, Germany