UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004234 |
|---|---|
| Receipt number | R000005090 |
| Scientific Title | Multicenter epidemiological observation study on intra-abdominal hypertension in Japan |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2018/09/28 13:51:42 |
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Basic information
Public title
Multicenter epidemiological observation study on intra-abdominal hypertension in Japan
Acronym
IAH-J
Scientific Title
Multicenter epidemiological observation study on intra-abdominal hypertension in Japan
Scientific Title:Acronym
IAH-J
Region
| Japan |
Condition
Condition
Patients in ICU meet the criteria at risk on intra-abdominal hypertension by WSACS
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To document the epidemiological facts on IAH in the critically ill patients in Japan
Basic objectives2
Others
Basic objectives -Others
risk evaluation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical Data
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
WSACS defined IAH/ACS risk criteria
Key exclusion criteria
1) Patients who stay less than 24 hours in ICU, and/or 2) Trauma to the bladder, hematuria, bad bladder compliance
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Oda |
Organization
Tokyo Medical University
Division name
Emergency and Critical Care Medicine
Zip code
Address
6-7-1, Nishi-Shinjuku, Shinjuku, Tokyo, Japan
TEL
03-3342-6111
odajun@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Oda |
Organization
Tokyo Medical University
Division name
Emergency and Critical Care Medicine
Zip code
Address
6-7-1, Nishi-Shinjuku, Shinjuku, Tokyo, Japan
TEL
03-3342-6111
Homepage URL
junoda@v001.vaio.ne.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
DOB, Age, Sex, BMI
Diagnosis, complication
SAPS-II score, APACHE-II score
Injured date
Vital signs
Water balance
Intra-abdominal pressuire
BGA
Coagulation
Chemical exam
Drug
Parameter on Ventilation
Inclusion
-Low abdominal compliance
-Ileus
-Intra-abdominal hemorrhage/effusion
-Increased Permeability
-blood coagulation disorder
Exclusion
ICU stay<24h
Bladder injury/low compliance
Management information
Registered date
| 2010 | Year | 09 | Month | 19 | Day |
Last modified on
| 2018 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005090
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
