Iloprost in High Risk Cardiac Surgical Patients (Ilocard)

Ludwig Maximilian University of Munich

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: Isotonic Sodium Chloride solution 0.9 % (placebo); Drug: Iloprost (Ventavis)

Study type: Interventional

Funder types: Other

Identifiers

NCT00927654

2008-002090-12

Details and patient eligibility

About

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.

Enrollment: 253 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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253 participants in 2 patient groups, including a placebo group

Iloprost

Experimental group

Treatment:

Drug: Iloprost (Ventavis)

Isotonic Sodium Chloride solution 0.9 %

Placebo Comparator group

Treatment:

Drug: Isotonic Sodium Chloride solution 0.9 % (placebo)