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: 13.1 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Ventavis
Pharmaceutical Form: Inhalation vapour, solution
CAS Number: 8000050524
Other descriptive name: ILOPROST TROMETAMOL
Concentration unit: µg/ml microgram(s)/millilitre
Concentration
Sponsors
Hospital of the university of munich
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of the cardio pulmonary morbidity in high risk cardiac surgical patients by means of prophylactic administration of Iloprost.;Secondary Objective: Investigation of the efficacy and safety of Iloprost in cardiac surgery.;Primary end point(s): Duration of post-operative artificial respiration after arrival on intensive care unit.;Timepoint(s) of evaluation of this end point: 2-3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Frequency of primary weaning failure from HLM • Frequency of right heart failure after end of bypass and during the first 24 hours postoperatively • Prevalence of pulmonary hypertension (mean PAP > 25 mmHg) immediately after closure of thorax and during the first 9 +/- 3 hours after arrival on ICU • Prevalence of ALI (PaO2/FiO2 < 300 mmHg) immediately after closure of thorax and during the first 9 +/- 3 houts after arrival on ICU • scue therapy with NO or Iloprost during surgery • Necessity of vasopressors and inotropics 9 +/- 3 hours after arrival on ICU • Changes of inflammatory parameters (TNF-a,IL-6) and cell composition in plasma and BAL liquid. • Duration of intensive stay • 90 days letality • Duration of hospital stay;Timepoint(s) of evaluation of this end point: 90 days (90 days letality) | — |
Countries
Germany
Contacts
Public ContactDepartment for Clinical Research
CSC, Clinical Study Center
Outcome results
None listed