Acute respiratory distress syndrome requiring mechanical ventilation
Conditions
Interventions
Trade Name: Ventavis
Product Name: Ventavis
Pharmaceutical Form: Nebulisation solution
INN or Proposed INN: ILOPROST TROMETAMOL
CAS Number: 73873-87-7
Concentration unit: µg microgram(s)
Concentration
Sponsors
University Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. PaO2/ FiO2 = 300 2. Bilateral opacities on frontal chest radiograph, and 3. requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation 4. no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg. 5. The term “acute onset” is defined as following: the duration of the hypoxemia criterion (#i) and the chest radiograph criterion (#ii) must be = 28 days at the time of randomization. Patients must be enrolled within 48 hours of onset of ARDS and no later than 7 days from the initiation of mechanical ventilation. 6. Subject’s Age = 18 years 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Subject’s Age < 18 years 2. More than 7 days since initiation of mechanical ventilation 3. more than 48 hours since onset of ARDS 4. Patient, surrogate or physician not committed to full intensive care support. 5. Positive Pregnancy test at the time of screening. 6. Contraindications for Iloprost: Conditions where the effects of Iloprost on platelets might increase the risk of hemorrhage (e.g. active peptic ulcers, trauma, intracranial hemorrhage), severe coronary heart disease, myocardial infarction (within the last 6 months), decompensated heart failure, severe arrhythmias, unstable angina pectoris, pulmonary arterial hypertension caused by occlusion of pulmonary veins, cerebrovascular events (e.g. transient ischemic attack, stroke) within the last 3 months, congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension, patients taking Direct Thrombin Inhibitors within previous 24h before study randomization. 7. Patients having NO Therapy within the previous 24h before study randomization 6. 7.8. Patients who received Iloprost treatment for any indication within 48 hours prior to the enrolment into the clinical trial 8.9. Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug 9.10. Subject (male or female) is not willing to use highly effective methods of contraception according to the “Clinical trial fertility group” recommendations (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment and for 28 days (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasoing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.Improvement of oxygenation (defined as paO2/FiO2 ratio);Secondary Objective: 2.Overall survival in 90-day follow-up period (90 day all-cause mortality). 3.SOFA Organ failure Scores at day 1-14, 28 and 90 4.duration of mechanical ventilation support 5.ICU length of stay 6.Ventilator associated pneumonia 7.Barotrauma 8.Pulmonary hemorrhage 9.Gastrointestinal hemorrhage 10.Pulmonary embolism 11.Delirium 12.ICU acquired weakness 13.Discharge Location (home, skilled nursing facility, rehabilitation) ;Primary end point(s): Improvement of oxygenation (defined as PaO2/FiO2 ratio);Timepoint(s) of evaluation of this end point: during ICU lengh of stay | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival in 90-day follow-up period (90 day all cause mortality) SOFA Organ failure scores duration of mechanical ventilation support ICU length of stay Ventilator associated pneumonia Barotrauma gastrointestinal hemorrhage pulmonary embolism Delirium ICU aquired weakness discharge location;Timepoint(s) of evaluation of this end point: During ICU length of stay | — |
Countries
Germany
Contacts
Public ContactIntensive Care Unit
University Department of Anesthesia and intensive care
Outcome results
None listed