drugset / Trial / NCT00464204

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

NCT00464204

Phase 3 Completed 196 enrolled Fresenius Kabi
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-07
Primary completion
2010-05
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator NaCl Unknown Intravenous
Subject Volulyte Other / unclassified Intravenous