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

Fresenius Kabi

Status and phase: Completed; Phase 3

Conditions: Sepsis

Treatments: Drug: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®"; Drug: 0.9 % NaCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00464204

2006-004350-25 (EudraCT Number)

06-HE06-01

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe sepsis
• Requirement for fluid resuscitation

Exclusion criteria

• serum creatinine > 300µmol/L
• Chronic renal failure
• Anuria lasting more than 4 hours
• Requirement for renal support

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 2 patient groups

Voluven® Arm

Experimental group

Treatment:

Drug: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®"

0.9 % NaCl

Active Comparator group

Treatment:

Drug: 0.9 % NaCl