EUCTR2006-004350-25-FR进行中（未招募）1 期
Crystalloids or colloids in patients with severe sepsis: effects on hemodynamics and tolerability of enteral nutrition - CRYSTMAS protocol (CRYSTalloids Morbidity Associated with severe Sepsis)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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) 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
排除标准
- •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is not available at the time of randomization, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the test result becomes available and is positive) d) Known hypersensitivity to HydroxyEthylStarch e) Known serum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or an available value is older than 24 hours, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the value becomes available and is 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
研究者
相似试验
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)Severe sepsisMedDRA version: 8.1Level: LLTClassification code 10040070Term: Septic shockEUCTR2006-004350-25-DEFresenius Kabi Deutschland GmbH197
已完成
不适用
Cristalloid versus colloid in patients with severe sepsis and septic shockSepsis, Septic shockInfections and InfestationsSepticemiaISRCTN25391663niversity Medical Center Utrecht (The Netherlands)60
尚未招募
不适用
Comparison of Crystalloids and Colloids in Acute Resuscitation of Trauma PatientsJPRN-UMIN000025236Jinnah Postgraduate Medical Centre516
进行中（未招募）
1 期
A comparison of crystalloids vs. colloids for intraoperative goal-directed fluid managementFluid optimization has been considered as major contributor to improved oxygen delivery, and thus improved outcome in patients. Hypovolemia has been associated with significant increases in morbidity and mortality. Administering volume deliberately, however, also may have undesired effects like hemodynamic deterioration, pulmonary edema, tissue edema, and decreased O2-delivery.EUCTR2005-004602-86-ATMedical University of Vienna1,112
已完成
不适用
Comparison of two different types of fluids on blood clotting parameters in patients undergoing neurosurgical proceduresCTRI/2022/02/040513PGIMER110