UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041357 |
|---|---|
| Receipt number | R000047218 |
| Scientific Title | Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in septic patients receiving mechanical ventilation: a retrospective single-center study |
| Date of disclosure of the study information | 2020/08/08 |
| Last modified on | 2022/02/09 21:06:05 |
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Basic information
Public title
Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in septic patients receiving mechanical ventilation: a retrospective single-center study
Acronym
Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in patients receiving mechanical ventilation
Scientific Title
Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in septic patients receiving mechanical ventilation: a retrospective single-center study
Scientific Title:Acronym
Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in patients receiving mechanical ventilation
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Septic patients often require mechanical ventilation, and effective ventilatory strategies can improve survival. The effects of permissive hypoxia and hyperoxia avoidance are unknown. This study aimed to examine these effects on outcomes in mechanically ventilated septic patients.
Basic objectives2
Others
Basic objectives -Others
This study aimed to examine the effects of permissive hypoxia and hyperoxia avoidance on outcomes in mechanically ventilated septic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ICU mortality
Key secondary outcomes
Base
Study type
Observational
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
adult septic patients requiring mechanical ventilation who had been admitted to an intensive care unit (ICU)
Key exclusion criteria
child
Target sample size
213
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Umegaki |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1191
Address
2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan
TEL
+81-72-804-0101
umegakit@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Umegaki |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1191
Address
2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan
TEL
+81-72-804-0101
Homepage URL
umegakit@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan
Tel
+81-72-804-0101
umegakit@hirakata.kmu.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 | 08 | Month | 08 | 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
213
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective before-after study
Management information
Registered date
| 2020 | Year | 08 | Month | 08 | Day |
Last modified on
| 2022 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047218
