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Iloprost in Acute Respiratory Distress Syndrome (ThIlo)

Primary Purpose

Respiratory Distress Syndrome, Adult

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Iloprost
control
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring Acute respiratory distress syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Iloprost

control

Arm Description

Outcomes

Primary Outcome Measures

Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2
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

Overall survival in 90-day follow-up period
90 day all cause mortality
Sequential Organ Failure Assessment Score (SOFA Score)
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
Ventilation Support length
Number of Patients with the Occurence of Barotrauma
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
Significant Bleeding from Lung
Number of Patients with Gastrointestinal Hemorrhage
Significant Bleeding from GI Tract
Number of Patients with Pulmonary Embolism
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
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
Skeletal muscle dysfunction
Discharge Location
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)
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.

Full Information

First Posted
April 6, 2017
Last Updated
December 8, 2021
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03111212
Brief Title
Iloprost in Acute Respiratory Distress Syndrome
Acronym
ThIlo
Official Title
Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
August 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult
Keywords
Acute respiratory distress syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iloprost
Arm Type
Active Comparator
Arm Title
control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Iloprost
Intervention Description
Iloprost nebulized
Intervention Type
Drug
Intervention Name(s)
control
Intervention Description
sodium chloride 0,9% nebulized
Primary Outcome Measure Information:
Title
Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2
Description
partial pressure of oxygen in blood (PaO2), in millimeters of mercury divided by the fraction of oxygen in the inhaled air (FiO2)
Time Frame
Day 6 of Study
Secondary Outcome Measure Information:
Title
Overall survival in 90-day follow-up period
Description
90 day all cause mortality
Time Frame
on day 90 after randomization and study entry
Title
Sequential Organ Failure Assessment Score (SOFA Score)
Description
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
Time Frame
until ICU discharge, estimated average = 14 days
Title
Duration of Mechanical Ventilation
Description
Ventilation Support length
Time Frame
until ICU discharge, estimated average = 14 days
Title
Number of Patients with the Occurence of Barotrauma
Description
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.
Time Frame
until ICU discharge, estimated average = 14 days
Title
Number of Patients with Pulmonary Hemorrhage
Description
Significant Bleeding from Lung
Time Frame
until ICU discharge, estimated average = 14 days
Title
Number of Patients with Gastrointestinal Hemorrhage
Description
Significant Bleeding from GI Tract
Time Frame
until ICU discharge, estimated average = 14 days
Title
Number of Patients with Pulmonary Embolism
Description
Blockage of an artery in the lungs by a embolus that has moved from elsewhere in the body to the lung
Time Frame
until ICU discharge, estimated average = 14 days
Title
Number of Patients with Delirium
Description
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.
Time Frame
until ICU discharge, estimated average = 14 days
Title
Number of Patients with ICU Acquired Weakness
Description
Skeletal muscle dysfunction
Time Frame
until ICU discharge, estimated average = 14 days
Title
Discharge Location
Description
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.
Time Frame
until ICU discharge, estimated average = 14 days
Title
Barthel Index (BI)
Description
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.
Time Frame
at 6 months after study inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rosenberger, MD
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32131881
Citation
Haeberle H, Prohaska S, Martus P, Straub A, Zarbock A, Marx G, Zago M, Giera M, Koeppen M, Rosenberger P. Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study. Trials. 2020 Mar 4;21(1):242. doi: 10.1186/s13063-020-4163-0.
Results Reference
derived

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Iloprost in Acute Respiratory Distress Syndrome

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