ISRCTN95690673已完成2 期
Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunction: a randomised placebo controlled trial
Belfast Health and Social Care Trust (UK)0 个研究点目标入组 60 人开始时间: 2010年9月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 23/01/2014:
- •1. Aged greater than 18 years, either sex
- •2. Acute lung injury (ALI) as defined by acute onset of:
- •2.1. Hypoxic respiratory failure (partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2] less than or equal to 40 kPa)
- •2.2. Bilateral infiltrates on chest X-ray consistent with pulmonary oedema
- •2.3. No clinical evidence of left atrial hypertension or if measured, a pulmonary arterial occlusion pressure (PAOP) less than or equal to 18 mmHg
- •2.4. Requirement for positive pressure mechanical ventilation via an endotracheal tube or tracheostomy
- •All ALI criteria above must occur within the same 24-hour period. The onset of ALI is when the last ALI criterion is met. Patients must be enrolled within 72 hours of ALI onset.
- •Previous inclusion criteria:
- •1. Aged greater than 18 years, either sex
- •2. Acute lung injury (ALI) as defined by acute onset of:
- •2.1. Hypoxic respiratory failure (partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2] less than or equal to 40 kPa)
- •2.2. Bilateral infiltrates on chest X-ray consistent with pulmonary oedema
- •2.3. No clinical evidence of left atrial hypertension or if measured, a pulmonary arterial occlusion pressure (PAOP) less than or equal to 18 mmHg
- •2.4. Requirement for positive pressure mechanical ventilation via an endotracheal tube or tracheostomy
- •All ALI criteria above must occur within the same 24-hour period. The onset of ALI is when the last ALI criterion is met. Patients must be enrolled within 48 hours of ALI onset.
排除标准
- •Current exclusion criteria as of 23/01/2014:
- •1. Aged less than 18 years
- •2. More than 48 hours from the onset of ALI
- •3. Pregnancy
- •4. Participation in a clinical trial of an investigational medicinal product within 30 days
- •5. Consent declined
- •6. Current treatment with KGF
- •7. Known hypersensitivity to palifermin or Escherichia coli derived proteins
- •8. Previous adverse reaction to palifermin
- •9. Active history of malignancy excluding haematological malignancies
- •10. Chronic liver disease with Child-Pugh score greater than 12
- •Previous exclusion criteria:
- •1. Aged less than 18 years
- •2. More than 48 hours from the onset of ALI
- •3. Pregnancy
- •4. Participation in a clinical trial of an investigational medicinal product within 30 days
- •5. Consent declined
- •6. Current treatment with KGF
- •7. Patients with pancreatitis
- •8. Known hypersensitivity to palifermin or Escherichia coli derived proteins
- •9. Previous adverse reaction to palifermin
- •10. History of active malignancy
- •11. Chronic liver disease with Child-Pugh score greater than 12
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