Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients with acute respiratory failure requiring intubation. In this substudy, the investigators evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.
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
- •Age > 18 years
- •Admitted to the ICU no longer than 12 hrs before study entry
- •Intubated because of ventilation insufficiency no longer than 48 hrs before study entry
- •Clinically expected stay in the ICU > 48 hrs
- •Informed consent
排除标准
- •Pregnant or nursing
- •Total leukocyte count of > 50,000/mm3
- •Administration of filgrastim, sargramostim, or other biological response modifiers within 7 days before study entry
- •Known hypersensitivity or allergic reaction to Escherichia coli-derived products
- •Participation in another drug study
研究组 & 干预措施
Filgrastim
Filgrastim 300 microgr/day subcutaneously for 7 days
干预措施: Filgrastim (Drug)
结局指标
主要结局
Number of adverse events
时间窗: up to 28 days
the number of patients developing ARDS, disseminated intravascular coagulation or acute renal failure during days 1-28, and changes in MOD score during days 1-7.
次要结局
- follow up measures(Up to day 90)
研究者
Kirsi-Maija Kaukonen
MD, PhD
Helsinki University Central Hospital