NCT02715466终止4 期
Prospective, Controlled, Double-Blind, Randomized Multicentric Study On The Efficacy And Safety Of An Early Target Controlled Plasma Volume Replacement Therapy With A Balanced Gelatine Solution vs A Balanced Electrolyte Solution In Patients With Severe Sepsis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 12
- 主要终点
- Time Until First/Initial Hemodynamic Stabilization
研究概览
简要总结
This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years of age
- •Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
- •Patients with body weight ≤ 140 kg
- •Patients diagnosed severe sepsis / septic shock at admission on Intensive Care Unit who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during Intensive Care Unit stay who can be enrolled within 90 min after diagnosis
- •Patients where antibiotic therapy has already been started (prior to randomization)
- •Patient who are fluid responsive. Fluid responsiveness is defined as increase of > 10% in mean arterial pressure (MAP) after passive leg raising (PLR)
- •Signed informed consent by patient, legal representative or authorized person or deferred consent
排除标准
- •Administration of HES, dextrane solutions or > 500 ml of Gelatin solutions within the 24 h prior to randomization
- •Death expected within the next 48 h (moribund patients as defined by ASA ≥ class V)
- •Patients for whom the need of pressure infusions are expected
- •Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
- •Requirement for renal support (either continuous or discontinuous techniques, including intermittent haemodialysis, haemofiltration and haemodiafiltration)
- •Patients receiving therapeutic heparin medication due to chronic coagulation disease / anticoagulation medication (i.e. partial thromboplastin time > 60 sec)
- •Acutely burned patients
- •Contraindications according to summary of product characteristics of investigational test and reference product
- •Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
研究组 & 干预措施
Gelatine
Experimental
Balanced gelatine solution
干预措施: Balanced gelatine solution (Drug)
Gelatine
Experimental
Balanced gelatine solution
干预措施: Balanced electrolyte solution (Drug)
Electrolyte
Active Comparator
Balanced electrolyte solution
干预措施: Balanced electrolyte solution (Drug)
结局指标
主要结局
Time Until First/Initial Hemodynamic Stabilization
时间窗: 48 hours after treatment start
Time from first administration of IMP to first achievement of confirmed hemodynamic stability
次要结局
- Length of Stay (LOS) in the Intensive Care Unit (ICU)(Intensive care unit (ICU) discharge or day 28)
研究者
研究点 (12)
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