NCT02819453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

June 28, 2016

Last Update Submit

June 30, 2021

Conditions

Acute Respiratory Distress Syndrome

Keywords

corticosteroidacute respiratory distress syndrome

Outcome Measures

Primary Outcomes (5)

  • serum IL-18 level

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

    three days

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

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

    three days

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

    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.

    seven days

  • the ratio of Neutrophils/lymphocyte

    the ratio of Neutrophils/lymphocyte prior and after corticosteroid treatment

    three days

  • 45-day mortality after corticosteroid treatment

    45-day mortality of ARDS patients after corticosteroid treatment

    45 days

Secondary Outcomes (1)

  • factors associated with the mortality of ARDS patients

    45 days

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients diagnosed with acute respiratory distress syndrome (ARDS) based on Berlin criterion by two clinicians

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (3)

  • 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.

    PMID: 22461369RESULT

  • 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.

    PMID: 34393800DERIVED

  • 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.

    PMID: 28422025DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jin-Fu Xu, PhD

    Shanghai Pulmonary Hospital, Shanghai, China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of respiratory department

Study Record Dates

First Submitted

June 28, 2016

First Posted

June 30, 2016

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

July 2, 2021

Record last verified: 2021-06

Locations

CN(1)