Iloprost in High Risk Cardiac Surgical Patients (Ilocard)

This study has been completed.
Sponsor:
Collaborator:
Algora
Information provided by (Responsible Party):
Prof. Dr. med. B. Zwissler, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00927654
First received: June 17, 2009
Last updated: January 4, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 90 days lethality [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 17, 2009
Last Updated: January 4, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
Iloprost
pulmonary hypertension
cardio pulmonary morbidity
high risk cardiac surgical patients

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Pharmaceutical Solutions
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014