E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Investigation of effects of the prophylactic inhalation of Iloprost during operation on perioperative morbidity and outcome in high risk cardiac surgical patients compared to placebo. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036727 |
E.1.2 | Term | Primary pulmonary hypertension |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Reduction of the cardio pulmonary morbidity in high risk cardiac surgical patients by means of prophylactic administration of Iloprost. |
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E.2.2 | Secondary objectives of the trial |
Investigation of the efficacy and safety of Iloprost in cardiac surgery. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of post-operative artificial respiration after arrival on intensive care unit. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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-α,IL-6) and cell composition in plasma and BAL liquid.
• Duration of intensive stay
• 90 days letality
• Duration of hospital stay |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
90 days (90 days letality) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is the date when the last patient has completed the Follow-Up contact (day 90). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |