Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05401812
Collaborator
(none)
120
5
22

Study Details

Study Description

Brief Summary

Acute respiratory distress syndrome (ARDS) is a clinical syndrome of inflammatory lung injury characterized by increased pulmonary vascular permeability, loss of aerated lung tissue, severe hypoxemia and impaired compliance. Despite the advance in the critical care technology, the mortality of ARDS remains high in the last decades. Glucocorticoids have profound anti-inflammatory actions through the pleiotropic effects of the glucocorticoid receptor, which are considering a promising pharmacological therapy to mitigate the inflammatory lung injury and subsequent fibrosis in ARDS. Previous clinical trials have repeatedly tested the efficacy of glucocorticoid therapy in ARDS; however, the data about hard outcomes, such as mortality, are inconsistent between these studies. Investigators designed a 3x2 factorial trial of glucocorticoid therapy in ARDS to test the effects of glucocorticoid dosages (dose 0, dose 0.5 mg/kg, and dose 1 mg/kg of methylprednisolone equivalence) and durations (prolonged and short duration) on the treatment efficacy. In addition, investigators will measure the change of inflammatory biomarkers for post-hoc analysis to explore whether biomarkers could be used to guide patient selection and steroid tapering.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous glucocorticoid therapy
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Factorial Trial of Glucocorticoid Therapy in Acute Respiratory Distress Syndrome: Optimizing Dosing Regimen and Developing Biomarker-guided Treatment
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Standard care without glucocorticoid therapy.

Experimental: Low dose and long treatment duration

Methylprednisolone equivalent dose 0.5 mg/kg/day for 5 days, followed by 0.25 mg/kg/day for 5 days.

Drug: Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone

Experimental: Low dose and short treatment duration

Methylprednisolone equivalent dose 0.5 mg/kg/day for 4 days,, followed by 0.25 mg/kg/day for 3 days.

Drug: Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone

Experimental: Moderate dose and long treatment duration

Methylprednisolone equivalent dose 1 mg/kg/day for 5 days, followed by 0.5 mg/kg/day for 5 days.

Drug: Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone

Experimental: Moderate dose and short treatment duration

Methylprednisolone equivalent dose 1 mg/kg/day for 4 days, followed by 0.5 mg/kg/day for 3 days.

Drug: Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone

Outcome Measures

Primary Outcome Measures

  1. Ventilator-free survival [28 days]

    Ventilator-free survival between control and intervention arms

Secondary Outcome Measures

  1. Glucocorticoid dose and ventilator-free survival [28 days]

    Ventilator-free survival between low-dose and moderate-dose glucocorticoid groups

  2. Glucocorticoid treatment duration and ventilator-free survival [28 days]

    Ventilator-free survival between long treatment duration and short treatment duration groups

  3. ICU mortality [Length of ICU stay up to 28 days]

    Between-group difference in mortality at ICU discharge

  4. Hospital mortality [Length of hospital stay up to 60 days]

    Between-group difference in mortality at hospital discharge

  5. 60-day mortality [60 days]

    Between-group difference in mortality by day 60

  6. Oxygenation on day 7 [7 days]

    Proportion of patients with a P/F ratio > 200 mmHg on day 7

  7. Rapid oxygenation improvement [3 days]

    Change in P/F ratios between day 1 and day 3

  8. Successful liberation from mechanical ventilation [Up to 60 days]

    Median time to successful liberation from mechanical ventilation

  9. Lymphocytopenia [7 days]

    Proportion of lymphocytopenia on day 7

  10. Blood glucose level [10 days]

    Peak blood glucose level during treatment

  11. Hyperglycemia [10 days]

    Proportion of patients with hyperglycemia during treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Moderate to severe ARDS with a P/F ratio < 200 mmHg

  2. On invasive mechanical ventilation

  3. The onset of ARDS < 72 hours

Exclusion Criteria:
  1. Age <20 years

  2. Receiving systemic glucocorticoid therapy

  3. Uncontrolled gastrointestinal bleeding

  4. Terminal cancer

  5. Post-operation or with large wound

  6. Considered by the primary care doctor to be either definitely indicated or definitely contraindicated for glucocorticoid therapy

  7. Anticipating to receive chemotherapy and immunotherapy in 3 months

  8. Uncontrolled fungal infection

  9. Post solid organ or bone marrow transplant

  10. Severe influenza without anti-viral therapy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05401812
Other Study ID Numbers:
  • 202012189MINB
First Posted:
Jun 2, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
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
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022