Corticosteroid Treatment for Acute Respiratory Distress Syndrome

NCT ID: NCT02819453

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

after corticosteroid treatment

Patients diagnosed with acute respiratory distress syndrome(ARDS) after corticosteroids treatment

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Jin-Fu Xu

Director of respiratory department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Fu Xu, PhD

Role: STUDY_DIRECTOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, China

Countries

China

References

Dolinay T, Kim YS, Howrylak J, Hunninghake GM, An CH, Fredenburgh L, Massaro AF, Rogers A, Gazourian L, Nakahira K, Haspel JA, Landazury R, Eppanapally S, Christie JD, Meyer NJ, Ware LB, Christiani DC, Ryter SW, Baron RM, Choi AM. Inflammasome-regulated cytokines are critical mediators of acute lung injury. Am J Respir Crit Care Med. 2012 Jun 1;185(11):1225-34. doi: 10.1164/rccm.201201-0003OC. Epub 2012 Mar 29.

Reference Type: RESULT

PMID: 22461369 (View on PubMed)

Yang JW, Jiang P, Wang WW, Wen ZM, Mao B, Lu HW, Zhang L, Song YL, Xu JF. The Controversy About the Effects of Different Doses of Corticosteroid Treatment on Clinical Outcomes for Acute Respiratory Distress Syndrome Patients: An Observational Study. Front Pharmacol. 2021 Jul 29;12:722537. doi: 10.3389/fphar.2021.722537. eCollection 2021.

Reference Type: DERIVED

PMID: 34393800 (View on PubMed)

Sweeney RM, McAuley DF. Prolonged glucocorticoid treatment in acute respiratory distress syndrome - Authors' reply. Lancet. 2017 Apr 15;389(10078):1516-1517. doi: 10.1016/S0140-6736(17)30953-4. No abstract available.

Reference Type: DERIVED

PMID: 28422025 (View on PubMed)

Other Identifiers

20150101

Identifier Type: -

Identifier Source: org_study_id