EUCTR2017-003855-47-ATActive, not recruitingPhase 1
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
Apeptico Forschung und Entwicklung GmbH0 sites95 target enrollmentStarted: January 16, 2018Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 95
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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 sever 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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
- •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
- •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
Investigators
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