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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001529-88-AT

Enrollment

Registered

2004-10-04

Start date

2004-11-08

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suffering from ARDS who need in the moment of enrolment artificial respiration

Interventions

Trade Name: Alprostapint 500µg Konzentrat zur Infusionsbereitung Product Name: Alprostapint 500 µg Konzentrat zur Infusionsbereitung Product Code: n.a.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ARDS according to definition on American European Consensus Conference on ARDS Mandatory artificial respiration ARDS duration =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy Haemorrhagic diathesis Cranial / Brain injuries Severe renal and hepatic diseases

Design outcomes

Primary

Measure	Time frame
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 ; 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. ;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	—

Measure

Time frame

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 ; 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. ;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

—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026