Status:
COMPLETED
Iloprost in High Risk Cardiac Surgical Patients
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Algora
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 sur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00927654
Start Date
June 1 2009
End Date
March 1 2012
Last Update
January 7 2013
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital of the university of Aachen
Aachen, Germany, 52074
2
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
3
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
4
Hospital of the university of Duesseldorf
Düsseldorf, Germany, 40225