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Iloprost in High Risk Cardiac Surgical Patients (Ilocard)

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Iloprost (Ventavis)
Isotonic Sodium Chloride solution 0.9 % (placebo)
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Iloprost, pulmonary hypertension, cardio pulmonary morbidity, high risk cardiac surgical patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital of the university of Aachen
  • Herz- und Diabeteszentrum NRW
  • Deutsches Herzzentrum Berlin
  • Hospital of the university of Duesseldorf
  • Hospital of the university of Frankfurt
  • Hospital of the university of munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Iloprost

Isotonic Sodium Chloride solution 0.9 %

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

90 days lethality

Full Information

First Posted
June 17, 2009
Last Updated
January 4, 2013
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Algora
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1. Study Identification

Unique Protocol Identification Number
NCT00927654
Brief Title
Iloprost in High Risk Cardiac Surgical Patients
Acronym
Ilocard
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Algora

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Iloprost, pulmonary hypertension, cardio pulmonary morbidity, high risk cardiac surgical patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iloprost
Arm Type
Experimental
Arm Title
Isotonic Sodium Chloride solution 0.9 %
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Iloprost (Ventavis)
Other Intervention Name(s)
Ventavis
Intervention Description
Twice 20 µg at day 0 (total dose 40 µg) intraoperatively
Intervention Type
Drug
Intervention Name(s)
Isotonic Sodium Chloride solution 0.9 % (placebo)
Intervention Description
Twice at day 0 intraoperatively
Primary Outcome Measure Information:
Title
Duration of post-operative artificial respiration after arrival on intensive care unit
Time Frame
2-3 months
Secondary Outcome Measure Information:
Title
90 days lethality
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Zwissler, Prof.Dr.med.
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the university of Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Hospital of the university of Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Hospital of the university of Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Hospital of the university of munich
City
Munich
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30756339
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.
Results Reference
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Iloprost in High Risk Cardiac Surgical Patients

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