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

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

Outcome

Met primary endpoint

paper Significantly less HES was used to reach HDS vs. NaCl PMID 22624531 ↗

registry Voluven® Arm vs NaCl 0.9 % Arm; p = 0.0185; Mean Difference (Final Values) -331 (95% CI -640 to -21) NCT00464204 ↗

Publications

• Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study. Crit Care. 2012 May 24;16(3):R94. doi: 10.1186/cc11358.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	NaCl	Unknown	—	Intravenous
Subject	Volulyte	Other / unclassified	—	Intravenous

Indications