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Trial record 2 of 3638 for:    corticosteroids

Corticosteroid Mediates Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT02819453
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: Methylprednisolone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Corticosteroid Mediates Acute Respiratory Distress Syndrome Via NLRP3 Inflammasome Signaling Pathway
Study Start Date : January 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Corticosteroid group
Patients with acute respiratory distress syndrome were treated with corticosteroid, which determined by two clinicians.
Drug: Methylprednisolone
Patients with acute respiratory distress syndrome needed treat with methylprednisolone, which determined by two clinicians.
Other Name: Corticosteroid




Primary Outcome Measures :
  1. IL-18 level in serum at baseline [ Time Frame: at baseline ]
    IL-18 level in serum were detected by Human IL-18 ELISA kit at baseline


Secondary Outcome Measures :
  1. IL-18 level in serum after corticosteroid treatment [ Time Frame: three days ]
    IL-18 level in serum were detected by Human IL-18 ELISA kit after corticosteroid treatment



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819453


Locations
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China, Shanghai
Shanghai Pulmonary Hospital , Tongji University
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Study Director: Jin-Fu Xu, PhD Shanghai Pulmonary Hospital, Shanghai, China

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin-Fu Xu, Director of respiratory department, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT02819453     History of Changes
Other Study ID Numbers: 20150101
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Keywords provided by Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China:
Corticosteroid
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents