ThIlo: Iloprost in Acute Respiratory Distress Syndrome

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT03111212
Collaborator
(none)
150
1
2
25.7
5.8

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Actual 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 :
Jun 25, 2019
Actual Primary Completion Date :
May 14, 2021
Actual Study Completion Date :
Aug 14, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Iloprost

Drug: Iloprost
Iloprost nebulized

Placebo Comparator: control

Drug: control
sodium chloride 0,9% nebulized

Outcome Measures

Primary Outcome Measures

  1. Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2 [Day 6 of Study]

    partial pressure of oxygen in blood (PaO2), in millimeters of mercury divided by the fraction of oxygen in the inhaled air (FiO2)

Secondary Outcome Measures

  1. Overall survival in 90-day follow-up period [on day 90 after randomization and study entry]

    90 day all cause mortality

  2. Sequential Organ Failure Assessment Score (SOFA Score) [until ICU discharge, estimated average = 14 days]

    The SOFA score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is assessed by 0=normal function to max 4 points=severe organ dysfunction Lowest Score is 0, the Maximums Score is 24; high Scores mean worse outcome

  3. Duration of Mechanical Ventilation [until ICU discharge, estimated average = 14 days]

    Ventilation Support length

  4. Number of Patients with the Occurence of Barotrauma [until ICU discharge, estimated average = 14 days]

    Barotrauma is damage to body tissue secondary to pressure difference in enclosed cavities within the body.Ventilator asynchrony, acute elevation of the plateau and peak pressures above 30 cmH2O, or sudden decrease of delivered tidal volume are result of barotrauma.

  5. Number of Patients with Pulmonary Hemorrhage [until ICU discharge, estimated average = 14 days]

    Significant Bleeding from Lung

  6. Number of Patients with Gastrointestinal Hemorrhage [until ICU discharge, estimated average = 14 days]

    Significant Bleeding from GI Tract

  7. Number of Patients with Pulmonary Embolism [until ICU discharge, estimated average = 14 days]

    Blockage of an artery in the lungs by a embolus that has moved from elsewhere in the body to the lung

  8. Number of Patients with Delirium [until ICU discharge, estimated average = 14 days]

    An organically caused decline from a previous baseline mental functioning, that develops over a short period of time, typically hours to days. Measured as occurence and length in time.

  9. Number of Patients with ICU Acquired Weakness [until ICU discharge, estimated average = 14 days]

    Skeletal muscle dysfunction

  10. Discharge Location [until ICU discharge, estimated average = 14 days]

    Number of Patients discharged to home without additional care (self-care), home with additional care (home health care) and other care facilities such as nursing homes. Measured as % of patients discharged to either of these locations.

  11. Barthel Index (BI) [at 6 months after study inclusion]

    Is a measure using an ordinal scale used to measure performance in activities of daily living (ADL). The original 10-item form of the BI consists of 10 common ADL activities including: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Items are rated in terms of whether individuals can perform activities independently, with some assistance, or are dependent (scored as 10, 5 or 0). Items are weighted according to the level of nursing care required.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Tuebingen Tuebingen Germany 72076

Sponsors and Collaborators

  • University Hospital Tuebingen

Investigators

  • Principal Investigator: Peter Rosenberger, MD, University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT03111212
Other Study ID Numbers:
  • ThIlo
First Posted:
Apr 12, 2017
Last Update Posted:
Dec 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2021