EUCTR2006-004350-25-DE进行中（未招募）不适用
Crystalloids or colloids in patients with severe sepsis: effects on hemodynamics and tolerability of enteral nutrition - CRYSTMAS protocol (CRYSTalloids Morbidity Associated with severe Sepsis)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 197
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. Prior written informed consent of the patient (if this is not possible, it will be necessary for the investigator to obtain initial informed consent according to country-specific requirements: In France an initial written informed consent by a patient’s family member [surrogate” consent] or, if a family member is not present at the time of inclusion, to sign a declaration for inclusion in an emergency situation. Patient informed consent will be obtained as soon as the patient’s condition allows it, i.e. when patient regains consciousness). In Germany the legally authorized representative has to provide the written informed consent or in his absence a declaration for inclusion in an emergency situation is to be signed by a consultant physician who is not involved in the study and who is independent of the investigational team.
- •b.Male or female patient aged 18 years or over
- •c.Presence of severe sepsis defined as
- •-Sepsis due to a known or suspected infection with 2 or more of the modified systemic inflammatory response syndrome (SIRS) criteria
- •Temperature (>38oC or <36oC)
- •Heart rate (>90 beats / minute)
- •Respiratory rate (>20 breaths / minute) or arterial carbon dioxide (PaCO2) <32 torr (<4.3 kPa)
- •White blood cells (WBC) >12,000 cells/mm3, <4000 cells/mm3, or >10% immature (band) forms
- •-Severe sepsis for less than 24 hours with at least one of the following characteristics
- •Ratio of partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) <250
- •Arterial pH <7.3 or serum lactate level >1.5 × ULN (upper limit of normal)
- •Hypotension:
- •Inadequately fluid resuscitated patients with a systolic blood pressure =90 mmHg or MAP =70 mmHg, or
- •Inadequately fluid resuscitated patients requiring vasopressors to maintain blood pressure within normal ranges
- •Urine output <0.5 mL/kg/hour in patients who are inadequately fluid resuscitated
- •Platelet count <80,000/ mm3
- •Acute alteration of mental status
- •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
排除标准
- •a) Volume expansion with > 3 L of fluids (crystalloids and/or colloids) since diagnosis of severe sepsis 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. If a creatinine value of > 300 µmol/L becomes available later, treatment with the study drug may be continued if the risk/benefit ratio for the individual patient is regarded as positive by the investigator) f) Known history of chronic renal failure (hemodialysis) g) Anuria lasting more than 8 hours (<50 mL urine output /8hours) 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 liver cirrhosis, AIDS n) Requirement for concomitant cancer therapy (e.g. chemotherapy, radiotherapy or surgery) from randomization until Day 8 o) Fluid overload p) Subject with fluid restriction q) Refractory septic shock defined as severe sepsis with hypotension unresponsive to adequate fluid resuscitation, along with the presence of hypoperfusion abnormalities or organ dysfunction as defined by Bone et al., 1992. Patients receiving inotropic or vasopressor agents may no longer be hypotensive by the time they manifest hypoperfusion abnormalities or organ dysfunctions, yet they would still be considered to have septic schock. Patients treated with low dose vasopressors are not excluded provided they are responsive to fluid resuscitation as demonstrated by an individual fluid challenge. Patients receiving norepinephrine (noradrenaline) or epinephrine (adrenaline) at a dose > 0.5µg/kg/mn or dopamine at a dose > 15µg/kg/mn at the timepoint Screening are not eligible for the study. r) Intracranial bleeding
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