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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008986
Receipt No. R000010269
Scientific Title Effectiveness of preoperative use of noninvasive ventilation (NIV) in patients with living donor liver transplantation
Date of disclosure of the study information 2012/09/27
Last modified on 2018/12/05

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Basic information
Public title Effectiveness of preoperative use of noninvasive ventilation (NIV) in patients with living donor liver transplantation
Acronym Preoperative use of noninvasive ventilation for living donor liver transplantation
Scientific Title Effectiveness of preoperative use of noninvasive ventilation (NIV) in patients with living donor liver transplantation
Scientific Title:Acronym Preoperative use of noninvasive ventilation for living donor liver transplantation
Region
Japan

Condition
Condition Living donor liver transplantation
Classification by specialty
Pneumology Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We study whether preoperative use of NIV for living donor liver transplantation may improve preoperative arterial blood gas and pulmonary function. Patients enrolled are randomly assigned to receive either standard treatment or NIV.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. arterial blood oxygen level
2. alveolar-arterial difference in partial pressure of oxygen
Key secondary outcomes 1. lung function testing (forced expiratory volume in one second (FEV1), FEV1/forced vital capacity, maximum mid-expiratory flow rate, respiratory muscle force)
2. preoperative chest X ray
3. postoperative arterial blood gas
4. postoperative pulmonary infection
5. postoperative death

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The patients receive NIV for 2 to 3 hours in the daytime. Pressure support is increased until the maximal level tolerated by the patients is reached.
Interventions/Control_2 The patients continue the current treatments.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Recipients of living donor liver transplantation.
2. Analysis of arterial blood gas reveals PaO2 as less than 60 mmHg or PaCO2 as more than 7.3 or analysis of nocturnal monitoring reveals PtCO2 more than 45 mmHg or SpO2 less than 90%.
Key exclusion criteria 1. recipients of emergency living donor liver transplantation
2. recipients of living donor liver retransplantation
3. Patients need to receive oxygen therapy or NIV therapy by analysis of arterial blood gas and nocturnal monitoring.
4. unstable asthma or mild chronic obstructive pulmonary disease (percent predicted FEV1)
5. pneumothorax within 6 months
6. patients complicated with chronic lung disease
7. patients complicated with acute infections.
8. patients received NIV
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Chin
Organization Graduate School of Medicine, Kyoto University
Division name Department of respiratory management and sleep control medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3852
Email chink@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hamada
Organization Graduate School of Medicine, Kyoto University
Division name Department of Respiratory Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3830
Homepage URL
Email sh1124@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of respiratory management and sleep control medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization nothing
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
Address
Tel
Email

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 京都大学病院(京都府)

Other administrative information
Date of disclosure of the study information
2012 Year 09 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 Terminated
Date of protocol fixation
2012 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
2015 Year 10 Month 31 Day
Date of closure to data entry
2015 Year 10 Month 31 Day
Date trial data considered complete
2015 Year 10 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 09 Month 26 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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