Iloprost in High Risk Cardiac Surgical Patients

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927654

Acronym

Ilocard

Enrollment

253

Registered

2009-06-25

Start date

2009-06-30

Completion date

2012-03-31

Last updated

2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Iloprost, pulmonary hypertension, cardio pulmonary morbidity, high risk cardiac surgical patients

Brief summary

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.

Interventions

DRUGIloprost (Ventavis)

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

DRUGIsotonic Sodium Chloride solution 0.9 % (placebo)

Twice at day 0 intraoperatively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
90 days lethality	90 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026