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Iloprost in Acute Respiratory Distress Syndrome (ThIlo)

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ClinicalTrials.gov Identifier: NCT03111212
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : August 8, 2019
Sponsor:
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
Estimated Primary Completion Date : October 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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03111212


Contacts
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Contact: Peter Rosenberger, MD +49707129 ext 86622 peter.rosenberger@med.uni-tuebingen.de
Contact: Helene A Haeberle, MD Helene.haeberle@med.uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Peter Rosenberger, MD       peter.rosenberger@med.uni-tuebingen.de   
Contact: Helene A Haeberle, MD       helene.haeberle@med.uni-tuebingen.de   
Sub-Investigator: Helene A Haeberle, MD         
Principal Investigator: Peter Rosenberger, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Peter Rosenberger, MD University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03111212     History of Changes
Other Study ID Numbers: ThIlo
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: October 2018
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, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents