NCT00927654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2009

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

June 17, 2009

Last Update Submit

January 4, 2013

Conditions

Pulmonary Hypertension

Keywords

Iloprostpulmonary hypertensioncardio pulmonary morbidityhigh risk cardiac surgical patients

Outcome Measures

Primary Outcomes (1)

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

    2-3 months

Secondary Outcomes (1)

  • 90 days lethality

    90 days

Study Arms (2)

Iloprost

EXPERIMENTAL
Drug: Iloprost (Ventavis)

Isotonic Sodium Chloride solution 0.9 %

PLACEBO COMPARATOR
Drug: Isotonic Sodium Chloride solution 0.9 % (placebo)

Interventions

Iloprost (Ventavis)DRUG

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

Also known as: Ventavis
Iloprost
Isotonic Sodium Chloride solution 0.9 % (placebo)DRUG

Twice at day 0 intraoperatively

Isotonic Sodium Chloride solution 0.9 %

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital of the university of Aachen

Aachen, 52074, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Hospital of the university of Duesseldorf

Düsseldorf, 40225, Germany

Location

Hospital of the university of Frankfurt

Frankfurt, 60590, Germany

Location

Hospital of the university of munich

Munich, 81377, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30756339DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

IloprostSodium Chloride

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Bernhard Zwissler, Prof.Dr.med.

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Clinic for Anesthesiology

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 25, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 7, 2013

Record last verified: 2013-01

Locations

DE(6)