Phase 3
Completed N=196
Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Source: ClinicalTrials.gov NCT00464204 ↗Enrolled (actual)
196
Serious AEs
49.5%
Results posted
Aug 2011
Primary outcomePrimary: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization — 1379; 1709 Milliliter — p=0.0185
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization |
1379; 1709 | 0.0185 sig |
| SECONDARY Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization |
11.8; 14.3 | — |
| SECONDARY Quantity of Study Drug in 4 Days |
2615; 2788 | — |
| SECONDARY Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition |
24.6; 26.9 | — |
| SECONDARY Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization |
25.9; 27.6 | — |
| SECONDARY Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition |
6877; 7429 | — |
| SECONDARY Length of Stay in the Intensive Care Unit (ICU) |
15.4; 20.2 | — |
| SECONDARY Length of Stay in the ICU |
40.0; 39.6 | — |
| SECONDARY Length of Stay in the Hospital |
56.1; 56.9 | — |
| SECONDARY Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4 |
6.9; 7.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00464204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.