UMIN-CTR Clinical Trial

Basic information
Public title	Corticosteroids for patients with acute respiratory distress syndrome; systematic review and meta-analysis.
Acronym	Corticosteroids for patients with acute respiratory distress syndrome; systematic review and meta-analysis.
Scientific Title	Corticosteroids for patients with acute respiratory distress syndrome; systematic review and meta-analysis.
Scientific Title:Acronym	Corticosteroids for patients with acute respiratory distress syndrome; systematic review and meta-analysis.
Region	Japan

Condition
Condition	Acute respiratory distress syndrome
Classification by specialty	Pneumology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the benefit and harms of steroids versus placebo or conservative therapy for patients with acute respiratory distress
Basic objectives2	Others
Basic objectives -Others	N/A
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Hospital mortality, the number of ventilator free days, and incidence of infection. If there will be no data of hospital mortality, we will collect 28-60days mortality as short-term mortality. Incidence of infection will collect data of the number of patients with infection during hospital stay. Hospital mortality and incidence of infection will integrate risk ratio. VFDs will integrate mean difference.
Key secondary outcomes	ICU mortality, ICU length of stay (LOS), hospital LOS, ventilator days and oxygenation. We will collect data of P/F ratio on study day 7 as oxygenation. ICU mortality will integrate risk ratio. ICU LOS, hospital LOS, ventilator days and P/F ratio will integrate mean difference.

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ARDS, which was diagnosed by American European Consensus (1994) or Berlin (2012) diagnosis criteria. We will also include patients with acute respiratory failure which is defined as follow: - An acute onset of hypoxemia, with P/F ratio 200 mmHg and less - Bilateral noncardiogenic pulmonary edema - No clinical evidence of increased left atrial hypertension or a pulmonary artery wedge pressure 18 mmHg and less in the presence of a pulmonary artery catheter.
Key exclusion criteria	- Cardiac edema - Hypercapnia without hypoxia - Contraindication of steroids - Diseases which steroids is effective - History of steroids use by some months before inclusion - No ventilation - Acute lung injury associated with immaturity and congenital malformations
Target sample size	0

Research contact person
Name of lead principal investigator	1st name Shodai Middle name Last name Yoshihiro
Organization	JA General Hospital
Division name	Pharmaceutical department
Zip code	738-8503
Address	1-3-3 jigozen, hatsukaiti-shi, HIROSHIMA 738-8503 JAPAN
TEL	0829-36-3111
Email	syoshihiro-ja@umin.ac.jp

Public contact
Name of contact person	1st name Shodai Middle name Last name Yoshihiro
Organization	JA General Hospital
Division name	Pharmaceutical department
Zip code	738-8503
Address	1-3-3 jigozen, hatsukaiti-shi, HIROSHIMA 738-8503 JAPAN
TEL	0829-36-3111
Homepage URL
Email	syoshihiro-ja@umin.ac.jp

Sponsor
Institute	JA General Hospital.
Institute
Department

Funding Source
Organization	N/A.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Pharmaceutical department, JA General Hospital
Address	1-3-3 jigozen, hatsukaiti-shi, HIROSHIMA 738-8503 JAPAN
Tel	0829-36-3111
Email	syoshihiro-ja@umin.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date	2020 Year 07 Month 05 Day
Last follow-up date	2020 Year 07 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1. Types of study to be included. We will include any randomized controlled trials. 2. Searches. The following electronic database will be used; MEDLINE, CENTRAL, and ICHUSHI Web. 3. Risk of bias assessment. Risk of bias will be classified as high, low or unclear by 2 or more reviewers. Any disagreements are resolved by discussion among reviewers. We will assess selection performance, detection attrition and reporting bias, and other potential risks of bias. 4. Strategy for data synthesis. 4.1. Summary measures Collected variables will be synthesized by using random-effects methods. We will create a 'Summary of findings table' using follow seven outcomes; hospital mortality, VFDs, incidence of infection, ICU mortality, ICU LOS, hospital LOS, and data of P/F ratio. Each outcomes will be checked the certainty of the evidence by risk of bias, inconsistency/heterogeneity, indirectness, imprecision and publication bias. Our conclusion will be presented by a Summary of findings table. 4.2. Assessment of heterogeneity We will assess heterogeneity by using visual inspection of forest plot, I2 statics and Cochran's Q statistic. 4.3. Subgroup analysis We will conduct subgroup analysis about timing, anti-inflammatory potency, duration of steroids and age for the primary outcomes. The anti-inflammatory potency will be divided into three categories of methylprednisolone equivalents. We will categorize duration of steroids by considering half-life of steroids. Age will divide into 18 and more years old or less than 18. 4.4. Publication bias Publication bias will be accessed by funnel plot and will use Egger's test (p value of less than 0.05 for a two-sided test) to assess reporting bias when 10 or more studies will be synthesized. 4.5. Sensitivity analysis We will exclude studies that do not clearly show compliance with the low tidal ventilation strategy and studies with the sequential stopping rule and high risk of bias for the primary outcomes.

Management information
Registered date	2020 Year 07 Month 05 Day
Last modified on	2020 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046815