Iloprost in High Risk Cardiac Surgical Patients

Overview

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.

Full Title of Study: “Effect of Iloprost Inhalation Before and During Extracorporeal Circulation (ECC) on Perioperative Morbidity and Outcome in High Risk Cardiac Surgical Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2012

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Iloprost
  • Placebo Comparator: Isotonic Sodium Chloride solution 0.9 %

Clinical Trial Outcome Measures

Primary Measures

  • Duration of post-operative artificial respiration after arrival on intensive care unit
    • Time Frame: 2-3 months

Secondary Measures

  • 90 days lethality
    • Time Frame: 90 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ludwig-Maximilians – University of Munich
  • Collaborator
    • Algora
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. med. B. Zwissler, Director Clinic for Anesthesiology – Ludwig-Maximilians – University of Munich
  • Overall Official(s)
    • Bernhard Zwissler, Prof.Dr.med., Principal Investigator, Ludwig-Maximilians – University of Munich

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