UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012220 |
|---|---|
| Receipt number | R000013765 |
| Scientific Title | Multicenter retrospective study of treatment with continuous regional arterial infusion in severe acute pancreatitis |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2017/05/13 23:26:13 |
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Basic information
Public title
Multicenter retrospective study of treatment with continuous regional arterial infusion in severe acute pancreatitis
Acronym
SAP-CRAI
Scientific Title
Multicenter retrospective study of treatment with continuous regional arterial infusion in severe acute pancreatitis
Scientific Title:Acronym
SAP-CRAI
Region
| Japan |
Condition
Condition
severe acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and the safety about treatment with continuous regional arterial infusion in severe acute pancreatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The mortality at discharge
Key secondary outcomes
The incidence of pancreatic infection, invasive procedure rate, the incedence of complication assosiated with catheter of arterial infusion,the number of mechanical ventilation days,length of ICU stay
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
| 17 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases that have been determined to be severe with the criteria of Ministry of Health, Labour and Welfare study group acute pancreatitis severity(2008)
Key exclusion criteria
None
Target sample size
255
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayasu Horibe |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Internal medicine
Zip code
Address
2-8-29Musashidai, Fuchu-shi, Tokyo , Japan
TEL
0423235111
masayasu.horibe@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayasu Horibe |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Internal medicine
Zip code
Address
2-8-29Musashidai, Fuchu-shi, Tokyo , Japan
TEL
0423235111
Homepage URL
masayasu.horibe@gmail.com
Sponsor or person
Institute
Japanese Society of Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
YES
Study ID_1
04
Org. issuing International ID_1
Japanese Society of Intensive Care Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都立多摩総合医療センター(東京)、Tokyo Metropolitan Tama Medical Center(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Continuous Regional Arterial Infusion of Protease Inhibitors has no Efficacy in the Treatment of Severe Acute Pancreatitis:
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
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
age,gender,Charlson index,prognosis factor,CT grade, CT Severity Index,extent of necrosis,Atlanta classification, APACHE2,CRAI(start time, the number of catheter, location of catheter), protease inhibitor, antibacterial agent, volume of infusion, tubal feeding, mechanical ventilation, blood purification therapy
Management information
Registered date
| 2013 | Year | 11 | Month | 05 | Day |
Last modified on
| 2017 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013765
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
