UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008986 |
|---|---|
| Receipt number | 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 11:25:38 |
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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
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
sh1124@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of respiratory management and sleep control medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010269
