Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
- Conditions
- Sepsis
- Interventions
- Drug: 0.9 % NaCl
- Registration Number
- NCT00464204
- Lead Sponsor
- Fresenius Kabi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
- Severe sepsis
- Requirement for fluid resuscitation
- serum creatinine > 300µmol/L
- Chronic renal failure
- Anuria lasting more than 4 hours
- Requirement for renal support
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Voluven® Arm 6 % Hydroxyethylstarch 130/0.4 = "Voluven®" - 0.9 % NaCl 0.9 % NaCl -
- Primary Outcome Measures
Name Time Method Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization 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 Outcome Measures
Name Time Method Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization until hemodynamic stabilization (up to 48 hours) Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization
Quantity of Study Drug in 4 Days 4 days Total quantity of study drug infused over four consecutive days in the ICU
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.
Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization up to 48 hours Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.
Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition 7 days This amount will be calculated from start of enteral nutrition until 7 am of day 8
Length of Stay in the Intensive Care Unit (ICU) Until discharge from ICU (up to day 90) 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).
Length of Stay in the ICU Until discharge from ICU (up to Day 90) 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).
Length of Stay in the Hospital Until discharge from hospital (up to day 90) 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).
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 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).
Trial Locations
- Locations (24)
CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale
🇫🇷Dijon, France
Hôpital Lapeyronie / CHU Montpellier, Département d'Anesthésie Réanimation
🇫🇷Montpellier, France
Hôpital Central, Service Anesthésie-Réanimation, Chirurgicale CHU
🇫🇷Nancy, France
Hôpital St Antoine, Réanimation Médicale
🇫🇷Paris, France
CH Roanne, Service de Réanimation
🇫🇷Roanne, France
CHI Poissy - St Germain en Laye, Site de St Germain en Laye
🇫🇷St. Germain en Laye, France
Hôpital Civil de Strasbourg, Service de Réanimation Médicale
🇫🇷Strasbourg, France
Centre Hospitalier de Metz, Réa Polyvalente
🇫🇷Metz, France
CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente
🇫🇷Corbeil-Essonnes, France
CH Manchester, Service de Réanimation Polyvalente
🇫🇷Charleville-Mézières, France
CH Meaux, Service de Réanimation
🇫🇷Meaux, France
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
Hôpital St Louis, Département Anesthésie et Réanimation Chirurgicale
🇫🇷Paris, France
CHU Nîmes, Service de Réanimation, Division Anesthésie-Réa Douleur Urgence, Groupe Hospitalo-Universitaire Caremeau,
🇫🇷Nîmes, France
Hôpital de la Source, Réanimation Polyvalente
🇫🇷Orléans, France
Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin der Westf. Wilhelms-Universität
🇩🇪Münster, Germany
Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin
🇩🇪Tübingen, Germany
Hôpital Saint-Joseph, Service de Réanimation Polyvalente
🇫🇷Paris, France
Klinik und Poliklinik für Anästhesiologie und Intensivtherapie - Universitätsklinikum Leipzig AöR
🇩🇪Leipzig, Germany