Severe sepsis MedDRA version: 8.1 Level: LLT Classification code 10040070 Term: Septic shock
Conditions
Interventions
Trade Name: Voluven
Pharmaceutical Form: Solution for infusion
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 60-
Trade Name: Chlorure de sodium 0,9% Fresenius
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Written informed consent b) Male or female patients aged 18 years or over c) Presence of severe sepsis d) Requirement for fluid resuscitation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Volume expansion with >1 L of fluids (crystalloids and/or colloids) during the period between admission to Intensive Care Unit and Screening b) Participation in another clinical study with an investigational drug or an investigational medical device within 30 days before Screening or during the study c) Known pregnancy; Female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum pregnancy test (if a test result is not available at the time of randomization, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the test result becomes available and is positive) d) Known hypersensitivity to HydroxyEthylStarch e) Known serum creatinine > 300 µmol/L, corresponding to 3.4 mg/dL (if a serum creatinine value is not available at the time of randomization or an available value is older than 24 hours, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the value becomes available and is > 300 µmol/L) f) Known history of chronic renal failure (hemodialysis) g) Anuria lasting more than 8 hours despite fluid resuscitation prior to randomization h) Requirement for renal support (either continuous or discontinuous techniques, including intermittent hemodialysis, hemofiltration and hemodiafiltration) i) History of known hemostatic disorders with clinical bleeding (hemophilia and known or suspected Willebrand disease) j) Burns >20% of body surface k) State of brain death l) Therapeutic limitations (see appendix 11, section 2, ‘Definitions’: “…the non-introduction or non-optimisation of one or several curative or organ failure support treatments, the consequence of which may be to bring forward the time of death.”) m) Known co-morbidities: Hematologic malignant disorders, neutropenia (polymorphonuclear leukocytes < 500/mm3), proven cirrhosis, AIDS n) Contraindication to early Enteral Nutrition o) Requirement for concomitant cancer therapy (e.g. chemotherapy, radiotherapy or surgery) p) Fluid overload q) Subject with fluid restriction r) Septic shock defined as severe sepsis with hypotension unresponsive to adequate fluid resuscitation, along with the presence of hypoperfusion and organ dysfunction. Patients treated with vasopressors are not excluded providing they are responsive to fluid resuscitation. s) Intracranial bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare hemodynamics and gastrointestinal dysfunction in patients suffering from severe sepsis who have received vascular fillings with Voluven (colloid treatment group) or NaCl 0.9% (crystalloid control group). Comparison between the two groups will be based on : * the amount of study drug (mL) required to achieve the initial hemodynamic stabilization, and * the total amount of calories received from enteral nutrition over 7 days;Secondary Objective: To explore the efficacy of Voluven® compared to NaCl 0.9% with respect to the following variables: • Time taken to achieve the initial hemodynamic stabilization. • Total quantity of study drug infused over 4 consecutive days on the intensive care unit. • Time to start of Enteral Nutrition. • Achievement of 80% of the theoretical (prescribed) calorie intake from Enteral Nutrition. • Lengths of stay in intensive care unit and hospital. • Area under the curve (AUC) of sepsis-related organ failure assessment (SOFA) score from Screening to Day 4.;Primary end point(s): Two primary variables with the following hierarchical order are defined: • Amount of study drug (mL) required to achieve the initial hemodynamic stabilization • Total amount of enteral calories during the first 7 days of Enteral Nutrition following the initial hemodynamic stabilization | — |
Countries
France, Germany
Outcome results
None listed