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The early phase of Acute Respiratory Distress Syndrome (ARDS) is characterized by intense alveolar inflammation. Corticosteroids have been used to treat ARDS for decades. Although their efficacy has been a subject of ongoing controversy, recent clinical practice guidelines for ARDS issued a weak recommendation in favor of corticosteroid use in early ARDS. However, the optimal dose and duration of corticosteroid therapy remain unclear. Low-dose, short-course regimens have been evaluated in clinical trials for severe pneumonia and COVID-19. However, no head-to-head comparisons have been conducted to evaluate the efficacy of prolonged versus short courses of corticosteroid therapy in ARDS.
To address this gap, the investigators designed a 3×2 factorial trial to assess corticosteroid therapy for ARDS, aiming to evaluate the effects of different doses (no steroid, medium-low dose, and medium dose) and durations (prolonged vs. short) on clinical outcomes. In addition, the investigators will measure changes in inflammatory biomarkers for post hoc analysis to explore whether these biomarkers could guide the selection of steroid regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Arm A) No steroids | Other | Standard care without corticosteroid therapy. |
|
| (Arm B) No steroids | Other | Standard care without corticosteroid therapy. |
|
| (Arm C) Steroids with low dose for 10 days | Experimental | Dexamethasone 0.1 mg/kg from day 1 to day 5 and 0.05 mg/kg from day 6 to day 10. |
|
| (Arm D) Steroids with low dose for 7 days | Experimental | Dexamethasone 0.1 mg/kg from day 1 to day 4 and 0.05 mg/kg from day 5 to day 7. |
|
| (Arm E) Steroids with medium dose for 10 days | Experimental | Dexamethasone 0.2 mg/kg from day 1 to day 5 and 0.1 mg/kg from day 6 to day 10. |
|
| (Arm F) Steroids with medium dose for 7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No steroids (Arm A) | Other | Standard care for ARDS without corticosteroids. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day ventilator-free survival | Proportion of ventilator-free survival at day 28 between intervention arms (arms C, D, E, and F) and control arms (arms A and B) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day ventilator-free survival between low and medium dose groups | Proportion of ventilator-free survival at day 28 between low dose (arm C and D) and medium dose (arm E and F) of corticosteroids. | 28 days |
| 28-day ventilator-free survival between long and short treatment duration groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng-Yuan Ruan, MD, PhD | Contact | 886223123456 | syruan@ntu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
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Dexamethasone 0.2 mg/kg from day 1 to day 4 and 0.1 mg/kg from day 5 to day 7. |
|
| Corticosteroids, low dose for 10 days |
| Drug |
Dexamethasone: low dose for 10 days |
|
| Corticosteroids, low dose for 7 days | Drug | Dexamethasone: low dose for 7 days |
|
| Corticosteroids, medium dose for 10 days | Drug | Dexamethasone: medium dose for 10 days |
|
| Corticosteroids, medium dose for 7 days | Drug | Dexamethasone: medium dose for 7 days |
|
| No steroids (Arm B) | Other | Standard care for ARDS without corticosteroids. |
|
Proportion of ventilator-free survival at day 28 between long-course treatment (arms C and E) and short-course treatment (arms D and F) |
| 28 days |
| ICU mortality | Proportion of death in the ICU | From ICU admission to discharge, an average of 21 days |
| 60-day mortality | Proportion of death in 60 days | 60 days |
| Oxygenation improvement on day 7 | Proportion of patients with PaO2/FiO2 ratio > 200 mmHg on day 7 | 7 days |
| Proportion of nosocomial infection | Proportion of nosocomial infection during hospitalization (up to 30 days) | 30 days |
| Proportion of lymphocytopenia | Proportion of lymphocytopenia in 10 days | 10 days |
| Hyperglycemia | Peak blood glucose level during initial 10 days | 10 days |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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