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Corticosteroid Treatment for Acute Respiratory Distress Syndrome

Corticosteroid Treatment for Acute Respiratory Distress Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02819453
Enrollment
105
Registered
2016-06-30
Start date
2015-01-31
Completion date
2017-12-31
Last updated
2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

corticosteroid, acute respiratory distress syndrome

Brief summary

It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence against viral and bacterial stimuli by modulating the immune response. The aim of this study was to determine IL-18 levels in serum of patients with acute respiratory distress syndrome and to investigate whether corticosteroid attenuate its levels. In addition, to explore the effect of corticosteroid therapy on the prognosis of ARDS.

Detailed description

The acute respiratory distress syndrome (ARDS) is caused by an inflammatory injury to the lung that is characterized clinically by acute hypoxemic respiratory failure. Pathologically complex changes in the lung are manifested by an early, exudative phase followed by proliferative and fibrotic phases. Persistent ARDS is characterized by ongoing inflammation, parenchymal-cell proliferation, and disordered deposition of collagen, all of which may be responsive to corticosteroid therapy. Systemic corticosteroids have been considered a potentially beneficial therapy. However, several studies have failed to provide convincing evidence to prove the efficacy of corticosteroids in decreasing the mortality of ARDS. For the secondary outcomes, such as oxygenation improvement and reduction of the duration of mechanical ventilation, have shown consistent findings in favor of corticosteroid therapy. However, the underlying mechanisms that account for the anti-inflammatory actions of corticosteroid in ARDS patients have not yet to be elucidated, and the activities do not appear to be controlled by a single mechanism. Interleukin-18 (IL-18), along with interleukin-1b (IL-1b), is produced by inflammasomes when activated by a number of pathogen, environmental or host-derived danger signals. Inflammasomes are innate immune regulatory protein complexes which seem to play a key role in the host immune response of patients with ARDS. The aim of this study is to determine the role of steroid on IL-18 levels in serum of patients with ARDS and its effect on prognosis.

Interventions

None listed

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

1. Able to provide written informed consent; 2. Aged 18-85 years; 3. Confirmed diagnosis of ARDS by Berlin criterion

Exclusion criteria

1. Active tuberculosis and disseminated fungal infection; 2. Chronic corticosteroid application 3. Patients with organ dysfunction, such as severe liver dysfunction, adrenal insufficiency, severe cardiopulmonary dysfunction; 4. Hypogammaglobulinemia or other autoimmune disease; 5. Acquired immunodeficiency syndrome; 6. Refuse to use corticosteroid; 7. Pregnant or nursing

Design outcomes

Primary

MeasureTime frameDescription
arterial partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2)three daysarterial partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2) prior and after corticosteroid treatment
serum IL-18 levelthree daysthe serum IL-18 level of ARDS patients detected by Human IL-18 ELISA kit prior and after corticosteroid treatment
the acute physiology and chronic health evaluation (APACHE II) scoreseven daysthe acute physiology and chronic health evaluation (APACHE II) score prior and after corticosteroid treatment. This score system on a scale range from 0 to 71 scores, the higher scores mean a worse outcome.
the ratio of Neutrophils/lymphocytethree daysthe ratio of Neutrophils/lymphocyte prior and after corticosteroid treatment
45-day mortality after corticosteroid treatment45 days45-day mortality of ARDS patients after corticosteroid treatment

Secondary

MeasureTime frameDescription
factors associated with the mortality of ARDS patients45 daysfactors associated with the mortality of ARDS patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026