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Iloprost in High Risk Cardiac Surgical Patients (Ilocard)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927654
First Posted: June 25, 2009
Last Update Posted: January 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Algora
Information provided by (Responsible Party):
Prof. Dr. med. B. Zwissler, Ludwig-Maximilians - University of Munich
  Purpose
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.

Condition Intervention Phase
Pulmonary Hypertension Drug: Iloprost (Ventavis) Drug: Isotonic Sodium Chloride solution 0.9 % (placebo) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Iloprost Inhalation Before and During Extracorporeal Circulation (ECC) on Perioperative Morbidity and Outcome in High Risk Cardiac Surgical Patients

Resource links provided by NLM:


Further study details as provided by Prof. Dr. med. B. Zwissler, Ludwig-Maximilians - University of Munich:

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

Secondary Outcome Measures:
  • 90 days lethality [ Time Frame: 90 days ]

Enrollment: 253
Study Start Date: June 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iloprost Drug: Iloprost (Ventavis)
Twice 20 µg at day 0 (total dose 40 µg) intraoperatively
Other Name: Ventavis
Placebo Comparator: Isotonic Sodium Chloride solution 0.9 % Drug: Isotonic Sodium Chloride solution 0.9 % (placebo)
Twice at day 0 intraoperatively

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927654


Locations
Germany
Hospital of the university of Aachen
Aachen, Germany, 52074
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Hospital of the university of Duesseldorf
Duesseldorf, Germany, 40225
Hospital of the university of Frankfurt
Frankfurt, Germany, 60590
Hospital of the university of munich
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Algora
Investigators
Principal Investigator: Bernhard Zwissler, Prof.Dr.med. Ludwig-Maximilians - University of Munich
  More Information

Responsible Party: Prof. Dr. med. B. Zwissler, Director Clinic for Anesthesiology, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00927654     History of Changes
Other Study ID Numbers: 2008-002090-12
First Submitted: June 17, 2009
First Posted: June 25, 2009
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Prof. Dr. med. B. Zwissler, Ludwig-Maximilians - University of Munich:
Iloprost
pulmonary hypertension
cardio pulmonary morbidity
high risk cardiac surgical patients

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents