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Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Intravenous glucocorticoid therapy

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, Corticosteroid, Glucocorticoid

Eligibility Criteria

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

Inclusion Criteria:

Moderate to severe ARDS with a P/F ratio < 200 mmHg
On invasive mechanical ventilation
The onset of ARDS < 72 hours

Exclusion Criteria:

Age <20 years
Receiving systemic glucocorticoid therapy
Uncontrolled gastrointestinal bleeding
Terminal cancer
Post-operation or with large wound
Considered by the primary care doctor to be either definitely indicated or definitely contraindicated for glucocorticoid therapy
Anticipating to receive chemotherapy and immunotherapy in 3 months
Uncontrolled fungal infection
Post solid organ or bone marrow transplant
Severe influenza without anti-viral therapy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Arm Label

Control

Low dose and long treatment duration

Low dose and short treatment duration

Moderate dose and long treatment duration

Moderate dose and short treatment duration

Arm Description

Standard care without glucocorticoid therapy.

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

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

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

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

Outcomes

Primary Outcome Measures

Ventilator-free survival

Ventilator-free survival between control and intervention arms

Secondary Outcome Measures

Glucocorticoid dose and ventilator-free survival

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

Glucocorticoid treatment duration and ventilator-free survival

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

ICU mortality

Between-group difference in mortality at ICU discharge

Hospital mortality

Between-group difference in mortality at hospital discharge

60-day mortality

Between-group difference in mortality by day 60

Oxygenation on day 7

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

Rapid oxygenation improvement

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

Successful liberation from mechanical ventilation

Median time to successful liberation from mechanical ventilation

Lymphocytopenia

Proportion of lymphocytopenia on day 7

Blood glucose level

Peak blood glucose level during treatment

Hyperglycemia

Proportion of patients with hyperglycemia during treatment

Full Information

NCT ID

NCT05401812

First Posted

January 2, 2022

Last Updated

May 30, 2022

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05401812

Brief Title

Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

Official Title

A Factorial Trial of Glucocorticoid Therapy in Acute Respiratory Distress Syndrome: Optimizing Dosing Regimen and Developing Biomarker-guided Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome, Corticosteroid, Glucocorticoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard care without glucocorticoid therapy.

Arm Title

Low dose and long treatment duration

Arm Type

Experimental

Arm Description

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

Arm Title

Low dose and short treatment duration

Arm Type

Experimental

Arm Description

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

Arm Title

Moderate dose and long treatment duration

Arm Type

Experimental

Arm Description

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

Arm Title

Moderate dose and short treatment duration

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intravenous glucocorticoid therapy

Intervention Description

Betamethasone, dexamethasone, or methylprednisolone

Primary Outcome Measure Information:

Title

Ventilator-free survival

Description

Ventilator-free survival between control and intervention arms

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Glucocorticoid dose and ventilator-free survival

Description

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

Time Frame

28 days

Title

Glucocorticoid treatment duration and ventilator-free survival

Description

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

Time Frame

28 days

Title

ICU mortality

Description

Between-group difference in mortality at ICU discharge

Time Frame

Length of ICU stay up to 28 days

Title

Hospital mortality

Description

Between-group difference in mortality at hospital discharge

Time Frame

Length of hospital stay up to 60 days

Title

60-day mortality

Description

Between-group difference in mortality by day 60

Time Frame

60 days

Title

Oxygenation on day 7

Description

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

Time Frame

7 days

Title

Rapid oxygenation improvement

Description

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

Time Frame

3 days

Title

Successful liberation from mechanical ventilation

Description

Median time to successful liberation from mechanical ventilation

Time Frame

Up to 60 days

Title

Lymphocytopenia

Description

Proportion of lymphocytopenia on day 7

Time Frame

7 days

Title

Blood glucose level

Description

Peak blood glucose level during treatment

Time Frame

10 days

Title

Hyperglycemia

Description

Proportion of patients with hyperglycemia during treatment

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Moderate to severe ARDS with a P/F ratio < 200 mmHg On invasive mechanical ventilation The onset of ARDS < 72 hours Exclusion Criteria: Age <20 years Receiving systemic glucocorticoid therapy Uncontrolled gastrointestinal bleeding Terminal cancer Post-operation or with large wound Considered by the primary care doctor to be either definitely indicated or definitely contraindicated for glucocorticoid therapy Anticipating to receive chemotherapy and immunotherapy in 3 months Uncontrolled fungal infection Post solid organ or bone marrow transplant Severe influenza without anti-viral therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sheng-Yuan Ruan

Phone

886223123456

018477@ntuh.gov.tw

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

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