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Iloprost in Acute Respiratory Distress Syndrome (ThIlo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03111212
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : August 19, 2021
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
The patients will be randomized into one of two groups. Both groups will receive standard care as is state of the art. The intervention group will receive Iloprost nebulized as inhalative therapy.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Drug: Iloprost Drug: control Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)
Actual Study Start Date : June 25, 2019
Actual Primary Completion Date : May 14, 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Active Comparator: Iloprost Drug: Iloprost
Iloprost nebulized

Placebo Comparator: control Drug: control
sodium chloride 0,9% nebulized

Primary Outcome Measures :
  1. overall survival [ Time Frame: 90 days ]
    all cause mortality in 90-day follow up-period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Horowitz index <300
  • Bilateral opacities on frontal chest radiograph
  • requirement of positive pressure ventilation
  • no clinical evidence of left atrial hypertension
  • enrollment within 48h of onset of ARDS
  • mechanical ventilation <7 days

Exclusion Criteria:

  • age <18 years
  • mechanical ventilation >7 days
  • patient, surrogate or physician not committed to full intensive care support
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03111212

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Contact: Peter Rosenberger, MD +49707129 ext 86622
Contact: Helene A Haeberle, MD

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University Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Peter Rosenberger, MD   
Contact: Helene A Haeberle, MD   
Sub-Investigator: Helene A Haeberle, MD         
Principal Investigator: Peter Rosenberger, MD         
Sponsors and Collaborators
University Hospital Tuebingen
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Principal Investigator: Peter Rosenberger, MD University Hospital Tuebingen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital Tuebingen Identifier: NCT03111212    
Other Study ID Numbers: ThIlo
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital Tuebingen:
Acute respiratory distress syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Platelet Aggregation Inhibitors
Vasodilator Agents