UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040955 |
|---|---|
| Receipt number | R000046764 |
| Scientific Title | Conservative fluid management for adult patients with acute respiratory distress syndrome: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/07/04 |
| Last modified on | 2022/07/03 23:01:02 |
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Basic information
Public title
Conservative fluid management for adult patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Acronym
SR of fluid management for ARDS
Scientific Title
Conservative fluid management for adult patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Scientific Title:Acronym
SR of fluid management for ARDS
Region
| Japan |
Condition
Condition
acute respiratory distress syndrome
Classification by specialty
| Pneumology | Anesthesiology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we will perform a systematic review and meta-analysis of the benefits and harms of conservative fluid management for adult patients with ARDS seeking for good practice to improve outcomes of ARDS.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Mortality; all-cause mortality at the latest time point available up to 90 days.
Key secondary outcomes
(2) Ventilator-free days
(3) Hemodynamic instability
(4) Acute kidney injury, need for renal replacement therapy
(5) Length of ICU stay
(6) Length of hospital stay
(7) Cognitive dysfunction or delirium
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion: Adults with ARDS diagnosed by the American-European Consensus Conference (AECC) criteria or the Berlin criteria.
Key exclusion criteria
Exclusion: Adolescents (under 18 years of age). Hemodynamic instability; need much fluid or blood infusion, much dose of vasopressors or inotropic agents to keep body pressure.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nakamori |
Organization
Graduate School of Medicine, Mie University
Division name
Department of Clinical Anesthesiology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL
059-232-1111
yunakamori@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nakamori |
Organization
Graduate School of Medicine, Mie University
Division name
Department of Clinical Anesthesiology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL
059-232-1111
Homepage URL
yunakamori@gmail.com
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
None
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
None
Address
None
Tel
None
None
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 | 04 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Japan Medical Abstracts Society. We will search all databases from their inception to the present. Non-English language articles such as those in Japanese will be also included in this analysis. We will also conduct a search of the WHO International Clinical Trials Registry Portal (ICTRP) and ClinicalTrials.gov for ongoing trials to analyze publication bias.
We will include only randomized controlled trials (RCTs) which compared two fluid strategies; the conservative fluid strategy or the liberal fluid strategy. We will include studies reported as full-text, those published as abstract only, and unpublished data.
More than two authors will independently assess risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will resolve any disagreements by discussion or by involving another author. We will assess the risk of bias according to the following domains.
1. Random sequence generation.
2. Allocation concealment.
3. Blinding of participants and personnel.
4. Blinding of outcome assessment.
5. Incomplete outcome data.
6. Selective outcome reporting.
7. Other bias (i.e. specific study design, baseline imbalance in participant characteristics, co-intervention imbalance, and sponsorship bias).
We will use the random-effects model and perform a sensitivity analysis with a fixed-effect model. If the review includes more than one comparison, which cannot be included in the same analysis, we will report the results for each comparison separately.
If data from the studies are sufficient, we will carry out subgroup analyses based on the type of strategy criteria; fluid monitoring, fluid dose and diuretics threshold. We will also perform subgroup analyses for each ARDS definition and severity classification.
Management information
Registered date
| 2020 | Year | 06 | Month | 30 | Day |
Last modified on
| 2022 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046764
