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Completed

NCT Number: NCT02819453

Corticosteroid Treatment for Acute Respiratory Distress Syndrome

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. serum IL-18 level

    Time frame: three days

    the serum IL-18 level of ARDS patients detected by Human IL-18 ELISA kit prior and after corticosteroid treatment

  2. arterial partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2)

    Time frame: three days

    arterial partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2) prior and after corticosteroid treatment

  3. the acute physiology and chronic health evaluation (APACHE II) score

    Time frame: 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.

  4. the ratio of Neutrophils/lymphocyte

    Time frame: three days

    the ratio of Neutrophils/lymphocyte prior and after corticosteroid treatment

  5. 45-day mortality after corticosteroid treatment

    Time frame: 45 days

    45-day mortality of ARDS patients after corticosteroid treatment

Secondary outcomes

  1. factors associated with the mortality of ARDS patients

    Time frame: 45 days

    factors associated with the mortality of ARDS patients

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2016
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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