Iloprost in High Risk Cardiac Surgical Patients

Phase 3

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Iloprost (Ventavis); Drug: Isotonic Sodium Chloride solution 0.9 % (placebo)

• Registration Number: NCT00927654
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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 surgical patients is investigated in comparison to placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-04
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iloprost	Iloprost (Ventavis)	-
Isotonic Sodium Chloride solution 0.9 %	Isotonic Sodium Chloride solution 0.9 % (placebo)	-

Primary Outcome Measures

Name	Time	Method
Duration of post-operative artificial respiration after arrival on intensive care unit	2-3 months

Secondary Outcome Measures

Name	Time	Method
90 days lethality	90 days

Trial Locations

Locations (6)

Hospital of the university of Aachen; 🇩🇪 Aachen, Germany

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Hospital of the university of munich; 🇩🇪 Munich, Germany

Hospital of the university of Duesseldorf; 🇩🇪 Duesseldorf, Germany

Hospital of the university of Frankfurt; 🇩🇪 Frankfurt, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany