Corticosteroid Treatment for Acute Respiratory Distress Syndrome

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China (Other)

Overall Status

Completed

CT.gov ID

NCT02819453

Collaborator

(none)

105

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome

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.

Study Design

Study Type:

Observational

Actual Enrollment :

105 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Corticosteroid Treatment for Acute Respiratory Distress Syndrome

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
prior corticosteroid treatment Patients diagnosed with acute respiratory distress syndrome(ARDS) by two clinicians on the first day of hospital admission (not receiving corticosteroids yet)
after corticosteroid treatment Patients diagnosed with acute respiratory distress syndrome(ARDS) after corticosteroids treatment

Outcome Measures

Primary Outcome Measures

serum IL-18 level [three days]
the serum IL-18 level of ARDS patients detected by Human IL-18 ELISA kit prior and after corticosteroid treatment
arterial partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2) [three days]
arterial partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2) prior and after corticosteroid treatment
the acute physiology and chronic health evaluation (APACHE II) score [seven days]
the 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/lymphocyte [three days]
the ratio of Neutrophils/lymphocyte prior and after corticosteroid treatment
45-day mortality after corticosteroid treatment [45 days]
45-day mortality of ARDS patients after corticosteroid treatment

Secondary Outcome Measures

factors associated with the mortality of ARDS patients [45 days]
factors associated with the mortality of ARDS patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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