Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Overview
- Phase
- Phase 3
- Intervention
- 6 % Hydroxyethylstarch 130/0.4 = "Voluven®"
- Conditions
- Sepsis
- Sponsor
- Fresenius Kabi
- Enrollment
- 196
- Locations
- 24
- Primary Endpoint
- Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Voluven® Arm
Intervention: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®"
0.9 % NaCl
Intervention: 0.9 % NaCl
Outcomes
Primary Outcomes
Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization
Time Frame: until hemodynamic stabilization (up to 48 hours)
Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.
Secondary Outcomes
- Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization(until hemodynamic stabilization (up to 48 hours))
- Quantity of Study Drug in 4 Days(4 days)
- Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition(Until start of enteral nutrition (up to 48 hours))
- Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization(up to 48 hours)
- Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition(7 days)
- Length of Stay in the Intensive Care Unit (ICU)(Until discharge from ICU (up to day 90))
- Length of Stay in the ICU(Until discharge from ICU (up to Day 90))
- Length of Stay in the Hospital(Until discharge from hospital (up to day 90))
- Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4(From Screening to Day 4)