Iloprost in Acute Respiratory Distress Syndrome

Overview

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.

Full Title of Study: “Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 14, 2021

Interventions

  • Drug: Iloprost
    • Iloprost nebulized
  • Drug: control
    • sodium chloride 0,9% nebulized

Arms, Groups and Cohorts

  • Active Comparator: Iloprost
  • Placebo Comparator: control

Clinical Trial Outcome Measures

Primary Measures

  • Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2
    • Time Frame: 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 Measures

  • Overall survival in 90-day follow-up period
    • Time Frame: on day 90 after randomization and study entry
    • 90 day all cause mortality
  • Sequential Organ Failure Assessment Score (SOFA Score)
    • Time Frame: 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
  • Duration of Mechanical Ventilation
    • Time Frame: until ICU discharge, estimated average = 14 days
    • Ventilation Support length
  • Number of Patients with the Occurence of Barotrauma
    • Time Frame: 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.
  • Number of Patients with Pulmonary Hemorrhage
    • Time Frame: until ICU discharge, estimated average = 14 days
    • Significant Bleeding from Lung
  • Number of Patients with Gastrointestinal Hemorrhage
    • Time Frame: until ICU discharge, estimated average = 14 days
    • Significant Bleeding from GI Tract
  • Number of Patients with Pulmonary Embolism
    • Time Frame: 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
  • Number of Patients with Delirium
    • Time Frame: 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.
  • Number of Patients with ICU Acquired Weakness
    • Time Frame: until ICU discharge, estimated average = 14 days
    • Skeletal muscle dysfunction
  • Discharge Location
    • Time Frame: 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.
  • Barthel Index (BI)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Tuebingen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Rosenberger, MD, Principal Investigator, University Hospital Tuebingen

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