Iloprost in High Risk Cardiac Surgical Patients (Ilocard)
This study has been completed.
Sponsor:
Ludwig-Maximilians - University of Munich
Collaborator:
Algora
Information provided by (Responsible Party):
Prof. Dr. med. B. Zwissler, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00927654
First received: June 17, 2009
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension |
Drug: Iloprost (Ventavis) Drug: Isotonic Sodium Chloride solution 0.9 % (placebo) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Iloprost Inhalation Before and During Extracorporeal Circulation (ECC) on Perioperative Morbidity and Outcome in High Risk Cardiac Surgical Patients |
Resource links provided by NLM:
Further study details as provided by Ludwig-Maximilians - University of Munich:
Primary Outcome Measures:
- Duration of post-operative artificial respiration after arrival on intensive care unit [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 90 days lethality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Enrollment: | 253 |
| Study Start Date: | June 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Iloprost |
Drug: Iloprost (Ventavis)
Twice 20 µg at day 0 (total dose 40 µg) intraoperatively
Other Name: Ventavis
|
| Placebo Comparator: Isotonic Sodium Chloride solution 0.9 % |
Drug: Isotonic Sodium Chloride solution 0.9 % (placebo)
Twice at day 0 intraoperatively
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927654
Locations
| Germany | |
| Hospital of the university of Aachen | |
| Aachen, Germany, 52074 | |
| Herz- und Diabeteszentrum NRW | |
| Bad Oeynhausen, Germany, 32545 | |
| Deutsches Herzzentrum Berlin | |
| Berlin, Germany, 13353 | |
| Hospital of the university of Duesseldorf | |
| Duesseldorf, Germany, 40225 | |
| Hospital of the university of Frankfurt | |
| Frankfurt, Germany, 60590 | |
| Hospital of the university of munich | |
| Munich, Germany, 81377 | |
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Algora
Investigators
| Principal Investigator: | Bernhard Zwissler, Prof.Dr.med. | Ludwig-Maximilians - University of Munich |
More Information
No publications provided
| Responsible Party: | Prof. Dr. med. B. Zwissler, Director Clinic for Anesthesiology, Ludwig-Maximilians - University of Munich |
| ClinicalTrials.gov Identifier: | NCT00927654 History of Changes |
| Other Study ID Numbers: | 2008-002090-12 |
| Study First Received: | June 17, 2009 |
| Last Updated: | January 4, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ludwig-Maximilians - University of Munich:
|
Iloprost pulmonary hypertension cardio pulmonary morbidity high risk cardiac surgical patients |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Iloprost |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013