UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014546 |
|---|---|
| Receipt number | R000016920 |
| Scientific Title | The effects of polymyxin B hemoperfusion on extra vascular lung water and pulmonary vascular permeability |
| Date of disclosure of the study information | 2014/07/13 |
| Last modified on | 2016/01/21 01:02:06 |
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Basic information
Public title
The effects of polymyxin B hemoperfusion on extra vascular lung water and pulmonary vascular permeability
Acronym
The effects of polymyxin B hemoperfusion on extra vascular lung water and pulmonary vascular permeability
Scientific Title
The effects of polymyxin B hemoperfusion on extra vascular lung water and pulmonary vascular permeability
Scientific Title:Acronym
The effects of polymyxin B hemoperfusion on extra vascular lung water and pulmonary vascular permeability
Region
| Japan |
Condition
Condition
Gastrointestinal perforation
Classification by specialty
| Gastrointestinal surgery | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of direct hemoperfusion with polymyxin B immobilized fiber (PMX-DHP) on extra vascular lung water and pulmonary vascular permeability, and whether they depend on serum cytokine levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Extra vascular lung water and pulmonary vascular permeability before, during and after PMX-DHP
Key secondary outcomes
Serum cytokine levels before, during and after PMX-DHP
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Insert catheters for VolumeView and FloTrac sensor, vascular access for direct hemoperfusion, either in operation rooms or intensive care unit. Cables are connected to EV1000 Clinical Platform (Edwards Lifesciences). Extravascular lung water (EVLW) and pulmonary vascular permeability index (PVPI) are monitored before, during and after PMX-DHP. Blood samples are also obtained at the same time.
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with PMX-DHP after gastrointestinal surgery
Key exclusion criteria
Severe respiratory disease, including patients with dissected lungs
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tasuku Yoshida |
Organization
Yokohama City University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2918
ytasuku@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tasuku Yoshida |
Organization
Yokohama City University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2918
Homepage URL
ytasuku@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japanm
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 13 | Day |
Last modified on
| 2016 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016920
