Acute Respiratory Distress SyndromeNCT02819453
Corticosteroid Treatment for Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult patients diagnosed with acute respiratory distress syndrome (ARDS) based on Berlin criterion by two clinicians
Who may be able to join
- Able to provide written informed consent;
- Aged 18-85 years;
- Confirmed diagnosis of ARDS by Berlin criterion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Pulmonary Hospital , Tongji University
Shanghai, Shanghai Municipality, 200000
About this study
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.
Read the 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
- Keywords
- corticosteroid, acute respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum IL-18 level
the serum IL-18 level of ARDS patients detected by Human IL-18 ELISA kit prior and after corticosteroid treatment
Measured: 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
Measured: 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.
Measured: seven days
the ratio of Neutrophils/lymphocyte
the ratio of Neutrophils/lymphocyte prior and after corticosteroid treatment
Measured: three days
45-day mortality after corticosteroid treatment
45-day mortality of ARDS patients after corticosteroid treatment
Measured: 45 days
Secondary outcomes (1)
factors associated with the mortality of ARDS patients
factors associated with the mortality of ARDS patients
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Jin-Fu Xu, PhD, Study director, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819453
- Sponsor's protocol ID
- 20150101
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2016
- Last updated
- 2 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22461369Yang 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.
PubMed 34393800Sweeney 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.
PubMed 28422025
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Treatment for Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02819453
- Acronym / sponsor ID
- 20150101
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- corticosteroid, acute respiratory distress syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients diagnosed with acute respiratory distress syndrome (ARDS) based on Berlin criterion by two clinicians
Key inclusion criteria (3 listed)
- Able to provide written informed consent;
- Aged 18-85 years;
- Confirmed diagnosis of ARDS by Berlin criterion
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
the ratio of Neutrophils/lymphocyte
Time frame: three days
the ratio of Neutrophils/lymphocyte prior and after corticosteroid treatment
45-day mortality after corticosteroid treatment
Time frame: 45 days
45-day mortality of ARDS patients after corticosteroid treatment
1 secondary outcome
factors associated with the mortality of ARDS patients
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Results publication: PubMed 22461369Dolinay 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.
- Derived from this study: PubMed 34393800Yang 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.
- Derived from this study: PubMed 28422025Sweeney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Fu Xu, PhD study director
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum IL-18 level (time frame: three days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819453, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.