Effect of Iloprost inhalation before and during extracorporeal circulation on perioperative morbidity and outcome in high risk cardiac surgical patients

Conditions: In this study effects of the intra operative, prophylactic inhalation of Iloprost (Ventavis) before and during extracorporal circulation on perioperative morbidity and outcome in high risk cardiac surgical patients is investigated in comparison to placebo.
MedDRA version: 13.1Level: LLTClassification code 10036727Term: Primary pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2008-002090-12-DE

Lead Sponsor: Hospital of the university of munich

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• written informed consent
• For females of childbearing potential: neg. pregnancy test
• Patients, male or female, 18 to 85 years old
• Elective open-heart surgery using heart-lung-machine
• Patients with increased risk to suffer from perioperative right heart failure, i.e.
- protracted surgery: multiple valvular transplant or expected bypass time exceeding 120 minutes and/or
- Patients with preoperativ known pulmonary hypertension and/or
- Patients with severe heart insufficiency (NYHA III or NYHA IV).

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

• Patient not able to give consent
• Pregnant or nursing patients
• Anamnestic known hypersensitivity to the used drug (Ventavis) and its ingredients or to drugs with a similar chemical structure
• Blood clotting disorder requiring treatment
• Trauma, intracerebral bleeding or apoplex within the last 3 months prior to surgery
• Primary oder secondary immundeficiency (e. g. Pre-treatment with steroids, cytostatics)
• Systemic infection
• Lung disorder with impaired gas exchange
• Lung transplantation
• Cardiac transplantation
• Implantation of LVAD
• Floride ulcus disorder
• Planned surgery in deep hypothermia and cardiac arrest
• Subconscious and psychiatric disordered patients
• Participation in another clinical trial within the last 30 days prior to study start und up to 30 days after end of study
• Previous participation in this study