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Completed

NCT Number: NCT00927654

Iloprost 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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital of the university of Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iloprost (Ventavis)

Drug

Twice 20 µg at day 0 (total dose 40 µg) intraoperatively

Other names: Ventavis

Isotonic Sodium Chloride solution 0.9 % (placebo)

Drug

Twice at day 0 intraoperatively

Primary outcomes

  1. Duration of post-operative artificial respiration after arrival on intensive care unit

    Time frame: 2-3 months

Secondary outcomes

  1. 90 days lethality

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Algora

Registry information

Official study title

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

Acronym: Ilocard

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 25, 2009
Registry last updated
Jan 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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