Iloprost in High Risk Cardiac Surgical Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Iloprost Inhalation Before and During Extracorporeal Circulation (ECC) on Perioperative Morbidity and Outcome in High Risk Cardiac Surgical Patients

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Drug: Iloprost (Ventavis)
* Drug: Isotonic Sodium Chloride solution 0.9 % (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent for females of childbearing potential: negative 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 min and/or patients with preoperative known pulmonary hypertension and/or patients with severe heart insufficiency (NYHA III or NYHA IV) 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 apoplexy within the last 3 months prior to surgery primary or secondary immune deficiency (e.g., pretreatment with steroids, cytostatics) systemic infection lung disorder with impaired gas exchange lung transplantation cardiac transplantation implantation of LVAD (left ventricular assist device) fluoride 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 and up to 30 days after end of study previous participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iloprost<br> | Drug: Iloprost (Ventavis)<br>* Twice 20 µg at day 0 (total dose 40 µg) intraoperatively<br>* Other names: Ventavis;|
| Placebo Comparator: Isotonic Sodium Chloride solution 0.9 %<br> | Drug: Isotonic Sodium Chloride solution 0.9 % (placebo)<br>* Twice at day 0 intraoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of post-operative artificial respiration after arrival on intensive care unit |  | 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 days lethality |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iloprost, pulmonary hypertension, cardio pulmonary morbidity, high risk cardiac surgical patients