Clinical trial NCT00927654: Iloprost in High Risk Cardiac Surgical Patients
Official title: Effect of Iloprost Inhalation Before and During Extracorporeal Circulation (ECC) on Perioperative Morbidity and Outcome in High Risk Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: Iloprost
pulmonary hypertension
cardio pulmonary morbidity
high risk cardiac surgical patients
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Algora
First posted: 2009-06-25
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Duration of post-operative artificial respiration after arrival on intensive care unit
timeFrame: 2-3 months
Secondary outcomes:
measure: 90 days lethality
timeFrame: 90 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Hospital of the university of Aachen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Duesseldorf
country: Germany
facility: Hospital of the university of Duesseldorf
city: Frankfurt
country: Germany
facility: Hospital of the university of Frankfurt
city: Munich
country: Germany
facility: Hospital of the university of munich
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Bernhard Zwissler, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winterhalter M, Rex S, Stoppe C, Kienbaum P, Muller HH, Kaufmann I, Kuppe H, Dongas A, Zwissler B; ILOCARD Investigators. Effect of iloprost inhalation on postoperative outcome in high-risk cardiac surgical patients: a prospective randomized-controlled multicentre trial (ILOCARD). Can J Anaesth. 2019 Aug;66(8):907-920. doi: 10.1007/s12630-019-01309-8. Epub 2019 Feb 12.