Iloprost in High Risk Cardiac Surgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Iloprost

Group Type EXPERIMENTAL

Iloprost (Ventavis)

Intervention Type DRUG

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

Isotonic Sodium Chloride solution 0.9 %

Group Type PLACEBO_COMPARATOR

Isotonic Sodium Chloride solution 0.9 % (placebo)

Intervention Type DRUG

Twice at day 0 intraoperatively

Interventions

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Iloprost (Ventavis)

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

Intervention Type DRUG

Isotonic Sodium Chloride solution 0.9 % (placebo)

Twice at day 0 intraoperatively

Intervention Type DRUG

Other Intervention Names

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Ventavis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No