A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S Inj.' in Adult Subjects With Community-Acquired Severe Sepsis or Septic Shock
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 214
- 试验地点
- 17
- 主要终点
- All cause mortality
研究概览
简要总结
This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.
详细描述
A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S inj.(Human Immunoglobulin G)' as an Adjuvant Therapy in Adult Subjects with Community-Acquired Severe Sepsis or 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe sepsis or septic shock, if all of the following criteria is satisfied.
- •Age ≥ 18 years
- •Proved or suspected infection in at least one site
- •pneumonia
- •urinary tract infection
- •intra-abdominal infection
- •primary bloodstream infection
- •skin and soft tissue infection
- •Three or more of the following
- •a core temperature ≥ 38° C or ≤ 36° C
- •a heart rate ≥ 90 beats/min
- •a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical ventilation for an acute process
- •a white blood cell count ≥ 12000/mm3 or ≤ 4000/ mm3 or immature neutrophils > 10%
- •Acute organ failure in one or more of the following
- •respiratory system
- •blood system
- •metabolic system
- •circulatory system
- •APACHE score ≥ 20 and ≤ 29
- •Patient can treatment with GCIV in ICU within at least 48 hours
- •Informed consent
排除标准
- •Pregnant or breast-feeding women
- •a weight > 100kg
- •discharged from the hospital at least 14 days prior to new admission
- •Transferred from another hospital staying more than 48 hours
- •allergy or shock of IVIG
- •Treated with IVIG within the 12 weeks immediately preceding enrolment in this study
- •IgA deficiency
- •Hypernatremia or hyperhydration
- •Proved or suspected HIV or AIDS patients(CD4+ <200mL)
- •Current participation in any study within the last 4 weeks
- •Do not resuscitate (DNR) status
- •Patient's death is considered imminent due to coexisting disease
- •physicians decision to exclude patients from this protocol
- •Immunocompromised patients
研究组 & 干预措施
Imunoglobulin G
The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days.
干预措施: Immunoglobulin G (Drug)
Placebo control
The enrolled patients will be randomized to receive supplementation of placebo (0.9% NaCl) in ICU within 48 hours after hospital arrival admission for 3 consecutive days.
干预措施: Immunoglobulin G (Drug)
结局指标
主要结局
All cause mortality
时间窗: 28th day
次要结局
- All cause mortality(7th day)
- Laboratory Test(7th Day)
- Course of SOFA subscores(5 Times: D-1, D1, D3, D5, D7)
- Duration of ICU and general ward admission(28 days)