Dose efficacy relation of inhalative prostaglandin I2 vs. inhalative prostaglandin E1 in patients with ARDS: comparison of efficacy with respect to paO2/FiO2 ratio, Qs/Qt and PAP.
Phase 1
- Conditions
- Patients suffering from ARDS who need in the moment of enrolment artificial respiration
- Registration Number
- EUCTR2004-001529-88-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
ARDS according to definition on American European Consensus Conference on ARDS
Mandatory artificial respiration
ARDS duration < 72 hours
Male, female patients aged 18 to 80 years
No cardiac genesis (cardiac echo or PCWP)
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
Exclusion Criteria
Pregnancy
Haemorrhagic diathesis
Cranial / Brain injuries
Severe renal and hepatic diseases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Main objective : maximum difference of the PaO2/FiO2 ratio between start of therapy and onset of the maximum effect of the inhaled PGI2 respectively PGE1<br><br> ;<br> Secondary Objective: Secondary objectives : Dosage effect relation of both substances for ABP (arterial blood pressure), PAP (pulmonary arterial pressure), CO (cardiac output) and PG (prostaglandine) degradation products. Change of these parameters for each dosage with respect to the initial value.<br> ;Primary end point(s): Maximum difference of the PaO2/FiO2 ratio between start of therapy and onset of the maximum effect of the inhaled PGI2 respectively PGE1
- Secondary Outcome Measures
Name Time Method