UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016616 |
|---|---|
| Receipt number | R000019267 |
| Scientific Title | Acid-base Balance & Oxygen management in patients required mechanical Ventilation - Evaluation study= |
| Date of disclosure of the study information | 2015/02/27 |
| Last modified on | 2019/06/09 09:38:31 |
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Basic information
Public title
Acid-base Balance & Oxygen management
in patients required mechanical Ventilation - Evaluation study=
Acronym
ABOVE study
Scientific Title
Acid-base Balance & Oxygen management
in patients required mechanical Ventilation - Evaluation study=
Scientific Title:Acronym
ABOVE study
Region
| Japan |
Condition
Condition
Critically ill patients required mechanical ventilation for more than 48 hours
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To observe how often hyperoxia and Hypoxia occurred.
2) To observe how physicians react for hyperoxia and hypoxia. (change PEEP and/or FIO2)?
3) How PEEP and FIO2 are combined?
4) To assess the association of maximum (hyper), minimum (hypo) and time weighted average of SpO2 with clinical outcomes (28 days mortality, Ventilator free days at 28 day, intensive care free days at 28 days)
5) To assess the association with the reaction of physicians to hyperoxia with clinical outcomes.
6) To observe mode, PEEP, end inspiratory plateau pressure, tidal volume and Acid base-balance including pH, PaCO2 and B.E.
7) To observe the incidence of alkaremia and acidemia in mechanical ventilation patients and assess its impact on clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28 days mortality
Key secondary outcomes
ICU free survival days within 28 days after admission in ICU
Mechanical ventilation free survival days within 28 days after admission in ICU
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Critically ill patients required mechanical ventilation for more than 48 hours
Key exclusion criteria
Pateints who considered at risk for imminent death.
Patients who required extra-corporeal membrane oxygenation (ECMO).
Patients who ask us not use their clinical infmroation.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Moritoki |
| Middle name | |
| Last name | Egi |
Organization
Kobe University Hospital
Division name
Department of anesthesiology
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN, 650-0017
TEL
078-382-6172
moriori@tg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Moritoki |
| Middle name | |
| Last name | Egi |
Organization
Kobe University Hospital
Division name
Department of anesthesiology
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN, 650-0017
TEL
078-382-6172
Homepage URL
moriori@tg8.so-net.ne.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
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
IRB comittee Kobe University hospital
Address
7-5-2 Kusunoki tyo, Kobe city, Hyogo
Tel
078-382-5111
moriori@tg8.so-net.ne.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
| 2015 | Year | 02 | Month | 27 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 25 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Patients demographics
We will collect information on age, sex, heights, weights, the day for ICU admission, the day for start MV, reasons for ICU admission (surgical and non-surgical, infection or non-infection, trauma or non-trauma) and Acute Physiology and Chronic Health Evaluation (APACHE) II score. We will also collect the reason for requirement of mechanical ventilation.
2) Oxygen administration and the staement of mechanical ventilation
3times per day(6:00-10:00, 14:00-18:00, 22:00-2:00) as much as patients were stable condition.
MODE of mechanical ventilation, PEEP level, Peak pressure, minute volume, respiratory rate, FIO2, SpO2
3) Arterial blood gas information
3times per day(6:00-10:00, 14:00-18:00, 22:00-2:00) as much as patients were stable condition.PH, PaCO2, PaO2, HCO3, B.E., Hb, SaO2, Na+, K+, Cl-, Ca++, Lactate
4) Albumin levels (daily)
5) Outcome
The status (dead or alive) at 28 days after admission in ICU.
The day for commence and decease of mechanical ventilation.
The day of ICU admission and discharge
The day of hospital admission and discharge
The day for requirement of renal replacement therapy
Management information
Registered date
| 2015 | Year | 02 | Month | 24 | Day |
Last modified on
| 2019 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019267
