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Completed

NCT Number: NCT03111212

Iloprost in Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

Respiratory Distress Syndrome, Adult Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Tuebingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ILOPROST

Drug

Iloprost nebulized

Control

Drug

sodium chloride 0,9% nebulized

Primary outcomes

  1. 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 outcomes

  1. Overall survival in 90-day follow-up period

    Time frame: on day 90 after randomization and study entry

    90 day all cause mortality

  2. 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

  3. Duration of Mechanical Ventilation

    Time frame: until ICU discharge, estimated average = 14 days

    Ventilation Support length

  4. 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.

  5. Number of Patients with Pulmonary Hemorrhage

    Time frame: until ICU discharge, estimated average = 14 days

    Significant Bleeding from Lung

  6. Number of Patients with Gastrointestinal Hemorrhage

    Time frame: until ICU discharge, estimated average = 14 days

    Significant Bleeding from GI Tract

  7. 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

  8. 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.

  9. Number of Patients with ICU Acquired Weakness

    Time frame: until ICU discharge, estimated average = 14 days

    Skeletal muscle dysfunction

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)

Acronym: ThIlo

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2017
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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