Pulmonary HypertensionPhase 3IlocardNCT00927654
Iloprost in High Risk Cardiac Surgical Patients
A Phase 3 study testing Iloprost (Ventavis) in people with Pulmonary Hypertension, run by Ludwig-Maximilians - University of Munich at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Iloprost (Ventavis)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 6 sitesGermany
- Study dates
- Jun 2009to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 16Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Hospital of the university of Aachen
Aachen, 52074
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Deutsches Herzzentrum Berlin
Berlin, 13353
Hospital of the university of Duesseldorf
Düsseldorf, 40225
Hospital of the university of Frankfurt
Frankfurt, 60590
Hospital of the university of munich
Munich, 81377
About this study
Official title: Effect of Iloprost Inhalation Before and During Extracorporeal Circulation (ECC) on Perioperative Morbidity and Outcome in High Risk Cardiac Surgical Patients
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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Iloprost (Ventavis), Isotonic Sodium Chloride solution 0.9 % (placebo)
- Keywords
- Iloprost, pulmonary hypertension, cardio pulmonary morbidity, high risk cardiac surgical patients
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost (Ventavis)Drug
Also called Ventavis
Twice 20 µg at day 0 (total dose 40 µg) intraoperatively
Isotonic Sodium Chloride solution 0.9 % (placebo)Drug
Twice at day 0 intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Iloprost | Experimental | Not described Receives: Drug: Iloprost (Ventavis) |
| Isotonic Sodium Chloride solution 0.9 % | Placebo comparator | Not described Receives: Drug: Isotonic Sodium Chloride solution 0.9 % (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of post-operative artificial respiration after arrival on intensive care unit
Measured: 2-3 months
Secondary outcomes (1)
90 days lethality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Algora
- Responsible party
- Principal investigator, Prof. Dr. med. B. Zwissler, Ludwig-Maximilians - University of Munich
- Investigators
- Bernhard Zwissler, Prof.Dr.med., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927654
- Sponsor's protocol ID
- 2008-002090-12
- Other IDs
- 2008
- Acronym
- Ilocard
- Status last verified
- Jan 2013
- First submitted
- 17 Jun 2009
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30756339
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iloprost Inhalation Before and During Extracorporeal Circulation (ECC) on Perioperative Morbidity and Outcome in High Risk Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT00927654
- Acronym / sponsor ID
- Ilocard / 2008-002090-12
- Conditions
- Pulmonary Hypertension
- Keywords
- Iloprost, pulmonary hypertension, cardio pulmonary morbidity, high risk cardiac surgical patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Algora
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iloprost | Experimental | Drug: Iloprost (Ventavis) |
| Isotonic Sodium Chloride solution 0.9 % | Placebo comparator | Drug: Isotonic Sodium Chloride solution 0.9 % (placebo) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.,
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost (Ventavis)Also: VentavisTwice 20 µg at day 0 (total dose 40 µg) intraoperatively | Drug | Iloprost |
| Isotonic Sodium Chloride solution 0.9 % (placebo)Twice at day 0 intraoperatively | Drug | Isotonic Sodium Chloride solution 0.9 % |
Primary outcome
Duration of post-operative artificial respiration after arrival on intensive care unit
Time frame: 2-3 months
1 secondary outcome
90 days lethality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- Derived from this study: PubMed 30756339Winterhalter 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.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Zwissler, Prof.Dr.med. principal investigator
Ludwig-Maximilians - University of Munich
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iloprost (Ventavis) in people with Pulmonary Hypertension, run by Ludwig-Maximilians - University of Munich at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of post-operative artificial respiration after arrival on intensive care unit (time frame: 2-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.