Iloprost in High Risk Cardiac Surgical Patients

Pulmonary Hypertension Clinical Trial

— Ilocard  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927654
• Other study ID #: 2008-002090-12
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2009
• Last updated: January 4, 2013
• Start date: June 2009
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Iloprost (Ventavis)
Twice 20 µg at day 0 (total dose 40 µg) intraoperatively
• Isotonic Sodium Chloride solution 0.9 % (placebo)
Twice at day 0 intraoperatively

Locations

Country	Name	City	State
Germany	Hospital of the university of Aachen	Aachen
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Hospital of the university of Duesseldorf	Duesseldorf
Germany	Hospital of the university of Frankfurt	Frankfurt
Germany	Hospital of the university of munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Algora

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of post-operative artificial respiration after arrival on intensive care unit		2-3 months	No
Secondary	90 days lethality		90 days	No