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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
196
Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs.
NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day, according to patient needs.
Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization
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.
Time frame: until hemodynamic stabilization (up to 48 hours)
Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization
Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization
Time frame: until hemodynamic stabilization (up to 48 hours)
Quantity of Study Drug in 4 Days
Total quantity of study drug infused over four consecutive days in the ICU
Time frame: 4 days
Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition
Time from start of fluid resuscitation with study drug to start of enteral nutrition.
Time frame: 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
Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.
Time frame: up to 48 hours
Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition
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Hôpital Sud, Unité de Réanimation Médicale
Amiens, France
Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente
Avignon, France
Centre Hospitalier de Belfort-Montbéliard, Service de Réanimation et Maladies Infectieuses, Site de Belfort
Belfort, France
CHU de Bicêtre, Dpt d'Anesthésie Réanimation Chir.
Bicêtre, France
Hôpital Avicenne, Service de Réanimation
Bobigny, France
Centre Hospitalier Fleyriat, Service de Réanimation Polyvalente
Bourg-en-Bresse, France
CH Manchester, Service de Réanimation Polyvalente
Charleville-Mézières, France
CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente
Corbeil-Essonnes, France
CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale
Dijon, France
CH Meaux, Service de Réanimation
Meaux, France
...and 14 more locations
This amount will be calculated from start of enteral nutrition until 7 am of day 8
Time frame: 7 days
Length of Stay in the Intensive Care Unit (ICU)
Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).
Time frame: Until discharge from ICU (up to day 90)
Length of Stay in the ICU
Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., worst possible value).
Time frame: Until discharge from ICU (up to Day 90)
Length of Stay in the Hospital
Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).
Time frame: 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
The Sepsis-related Organ Failure Assessment (SOFA) score in this study is reported for entire days, not for exact time points on a day. Potentially, more than one SOFA score may be available for the same day. In this case, the mean of the respective total scores was used for that day for calculation of Area Under the Curve (AUC). The SOFA score includes sub-scores for Respiration, Coagulation, Liver, Cardiovascular, Central Nervous System and Renal function and may range from 0 (worst outcome) to 4 (best outcome).
Time frame: From Screening to Day 4