Iloprost in High Risk Cardiac Surgical Patients

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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 surgical patients is investigated in comparison to placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborator: Algora
• Treatments: Iloprost

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