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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

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
overall survival [ Time Frame: 90 days ]
all cause mortality in 90-day follow up-period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03111212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iloprost in Acute Respiratory Distress Syndrome
Official Title  ICMJE Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Distress Syndrome, Adult
Intervention  ICMJE
  • Drug: Iloprost
    Iloprost nebulized
  • Drug: control
    sodium chloride 0,9% nebulized
Study Arms  ICMJE
  • Active Comparator: Iloprost
    Intervention: Drug: Iloprost
  • Placebo Comparator: control
    Intervention: Drug: control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2018)
150
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2017)
900
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Rosenberger, MD +49707129 ext 86622 peter.rosenberger@med.uni-tuebingen.de
Contact: Helene A Haeberle, MD Helene.haeberle@med.uni-tuebingen.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03111212
Other Study ID Numbers  ICMJE ThIlo
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Rosenberger, MD University Hospital Tuebingen
PRS Account University Hospital Tuebingen
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP