EUCTR2017-003855-47-DE进行中（未招募）1 期
Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate-to-severe ARDS - a randomised, placebo-controlled, double-blind trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 95
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
- •The study will enrol patients with pulmonary permeability oedema (EVLWI = 10) and moderate to severe ARDS admitted to an Intensive Care Unit (ICU) and under mechanical ventilation*. To be eligible to participate in this study, an individual must meet all the following criteria:
- •1.Informed consent (for details see Section 10.1.1)
- •2.Male or female =18 years of age
- •3.Patient has been admitted to an ICU, is mechanically ventilated (according to the ventilation and weaning protocol as outlined in the study protocol) and stable in this condition for at least 8 hours
- •4.Moderate and severe ARDS diagnosis as defined by the Berlin Definition:
- •Onset of ARDS within 1 week of a known clinical insult or new or worsening respiratory symptoms
- •Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules
- •Respiratory failure not fully explained by cardiac failure or fluid overload (origin of oedema)
- •PaO2/FiO2 = 200 mm Hg with Positive End-Expiratory Pressure (PEEP) =5 cm H2O
- •5.Verified ARDS diagnosis (moderate or severe according to BERLIN Definition) not older than 48 hours
- •6.Extravascular lung water index (EVLWI) = 10 mL/PBW, as assessed with a validated bedside measurement (single indicator transpulmonary thermodilution measurement with the PiCCO system)
- •7.Patient who meets criteria for extensive hemodynamic monitoring as per international intensive-care medicine standards
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of clinically relevant allergies or idiosyncrasies to solnatide
- •2. Known use of any other investigational or non-registered drug within 30 days prior to study enrollment
- •3. Severe state of septic shock with a Mean Arterial Pressure (MAP) = 65 mm Hg and serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation
- •4. An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g. severe malnutrition, severe neurological diseases, pulmonary fibrosis or COPD)
- •5. Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support. Patients should not be denied this procedure or the procedure should not be delayed to avoid exclusion from the study.
- •6. Neutrophil count < 0.3 x 10^9/L
- •7. Cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
- •8. Cachexia (BMI < 18.5 kg/m2)
- •9. Cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter
- •10. Skin burns involving more than 15% of body surface
- •11. Subjects who are extremely unlikely to survive more than 48 hours due to the acute conditions of the patient in the opinion of the Investigator
- •12. Subjects transferred from a hospital not participating in this study who are already planned to be re-transferred during the observation period
- •13. Subjects who are not expected to survive the next month because of an underlying uncorrectable medical condition or a do not resuscitate order
- •14. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
研究者
相似试验
已完成
4 期
comparison of effectiveness and safety of topical sequential therapy with tazarotene and calcitriol with monotherapy of calcitriol or tazarotene in patients with stable plaque psoriasis.CTRI/2020/03/023715nil120
已完成
2 期
The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07JPRN-UMIN000000504Saitama Breast Cancer Clinical Study Group (SBCCSG)30
招募中
1 期
Clinical efficacy and safety of sequential therapy with cryotherapy and topical tirbanibulin 1% in actinic keratoses in transplant recipients: a randomised clinical trial.MedDRA version: 20.0Level: PTClassification code: 10000614Term: Actinic keratosis Class: 100000004858Actinic keratosisCTIS2023-508091-11-00Clinica Universidad De Navarra40
进行中（未招募）
不适用
Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAIEUCTR2010-022049-88-DERoche Pharma AG
招募中
2 期
Investigation of efficacy and safety of Sequence treatment of Cabazitaxel administation after 3 courses of Docetaxel for castration-resistant prostate cancercastration-resistant prostate cancerCRPCJPRN-jRCTs031220683Taguchi Satoru20