UMIN-CTR Clinical Trial

Basic information
Public title	Early Light Sedation Increased the Duration of Mechanical Ventilation in Patients with Severe Lung Injury
Acronym	Early Light Sedation Increased the Duration of Mechanical Ventilation in Patients with Severe Lung Injury
Scientific Title	Early Light Sedation Increased the Duration of Mechanical Ventilation in Patients with Severe Lung Injury
Scientific Title:Acronym	Early Light Sedation Increased the Duration of Mechanical Ventilation in Patients with Severe Lung Injury
Region	Japan

Condition
Condition	Adult patients who were admitted to the ICU and received mechanical ventilation for at least 48 h
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we aimed to investigate whether light sedation in the first 48 h for the patients with severe lung injury who received mechanical ventilation affected their prognosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the 28-day all-cause 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients who were admitted to the ICU and received mechanical ventilation for at least 48 h
Key exclusion criteria	1.The patients who have already received Mechanical ventilation 24 hours or more at ICU admission 2.The patients who treated with Extracorporeal Membrane Oxygenation 3.The patients who ordered do-not-attempt-resuscitation (DNAR)
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Yoshiaki Middle name Last name Inoue
Organization	University of Tsukuba
Division name	Emergency and Critical Care Medicine, Faculty of Medicine
Zip code	305-8576
Address	2-1-1, Amakubo, Tsukuba, Ibaraki
TEL	029-853-3900
Email	yinoue@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Chie Middle name Last name Hatozaki
Organization	Tsukuba University of hospital
Division name	Intensive Care Unit
Zip code	305-8576
Address	2-1-1, Amakubo, Tsukuba, Ibaraki
TEL	029-853-3900
Homepage URL
Email	chiehatozaki@gmail.com

Sponsor
Institute	Tsukuba University of hospital
Institute
Department

Funding Source
Organization	Tsukuba University of hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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

IRB Contact (For public release)
Organization	Tsukuba University of hospital
Address	2-1-1, Amakubo, Tsukuba, Ibaraki
Tel	029-853-3900
Email	t-credo.adm[@]un.tsukuba.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	筑波大学附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 14 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	459
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	2018 Year 06 Month 13 Day
Date of IRB	2018 Year 08 Month 23 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 05 Month 14 Day
Last modified on	2020 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046098