Crystalloids or colloids in patients with severe sepsis: effects on hemodynamics and tolerability of enteral nutrition - CRYSTMAS protocol (CRYSTalloids Morbidity Associated with severe Sepsis)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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

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is not available at the time of randomization, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the test result becomes available and is positive) d) Known hypersensitivity to HydroxyEthylStarch e) Known serum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or an available value is older than 24 hours, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the value becomes available and is 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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