UMIN-CTR Clinical Trial

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
Email	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
Email	moriori@tg8.so-net.ne.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019267