EUCTR2012-001863-64-AT进行中（未招募）不适用
Proof of concept study in male and female intensive care patients to investigate the clinical effect of repetitive orally inhaled doses of AP301 on alveolar liquid clearance in acute lung injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •-age = 18
- •-intubated and mechanically ventilated male and female patients of the Intensive Care Units of the Department of Anesthesia, General Intensive Care and Pain Control
- •-meets the criteria of ALI (as defined by the American-European Consensus Conference on ALI/ ARDS):
- •-Onset of ALI within 48 hours
- •-Bilateral infiltrates seen on frontal chest radiograph
- •-PCWP = 18 mm Hg or no clinical evidence of left atrial hypertension
- •-paO2/ FiO2 ratio = 300 mm Hg
- •-EVLW in PiCCO® at screening = 8 ml/PBW
- •-Meeting criteria for extensive hemodynamic monitoring according to investigators discretion
- •-Informed consent:
- •-For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Medical Issues
- •History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product
- •Brainstem death at screening
- •Current evidence of septic shock as defined by the Surviving Sepsis Campaign (Presence of acute organ dysfunction secondary to infection plus hypotension with systolic blood pressure < 90 mm Hg or mean arterial pressure (MAP) < 70 mm Hg for not less than one hour which cannot be reversed with fluid resuscitation)
- •Neutrophil count <0.3 x 10^9 L
- •Patients under immunosuppression: high dose steroids (> 80 mg Prednisolone /d; > 300 mg hydrocortisone / d), cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
- •BMI < 18.5 or > 35
- •Pregnancy / lactation or intention to fall pregnant during the time course of the study
- •Women of childbearing potential who are not using adequate contraception
- •General Issues
- •Participation in other interventional drug trials
研究者
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