Iloprost in High Risk Cardiac Surgical Patients (Ilocard)

January 4, 2013 updated by: Prof. Dr. med. B. Zwissler, Ludwig-Maximilians - University of Munich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Hospital of the university of Aachen
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum Berlin
      • Duesseldorf, Germany, 40225
        • Hospital of the university of Duesseldorf
      • Frankfurt, Germany, 60590
        • Hospital of the university of Frankfurt
      • Munich, Germany, 81377
        • Hospital of the University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Iloprost
Drug: Iloprost (Ventavis)
Twice 20 µg at day 0 (total dose 40 µg) intraoperatively
Other Names:
  • Ventavis
PLACEBO_COMPARATOR: Isotonic Sodium Chloride solution 0.9 %
Drug: Isotonic Sodium Chloride solution 0.9 % (placebo)
Twice at day 0 intraoperatively

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
90 days lethality
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Algora

Investigators

  • Principal Investigator: Bernhard Zwissler, Prof.Dr.med., Ludwig-Maximilians - University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (ESTIMATE)

June 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-002090-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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