UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001409 |
|---|---|
| Receipt number | R000001712 |
| Scientific Title | Epidemic Research on Acute Mesenteric Ischemia in Japan |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2015/04/06 12:31:19 |
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Basic information
Public title
Epidemic Research on Acute Mesenteric Ischemia in Japan
Acronym
ERAMI-J
Scientific Title
Epidemic Research on Acute Mesenteric Ischemia in Japan
Scientific Title:Acronym
ERAMI-J
Region
| Japan |
Condition
Condition
Acute Mesenteric Ischemia
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidental rates and mortality rates of individual types of acute mesenteric ishemia and prognostic factors on mortality.
Basic objectives2
Others
Basic objectives -Others
prognostic factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
in-hospital mortality
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
Patients who were admitted between Feb 1st 2002 and Jan 31st 2007, and were diagnosed with AMI by diagnostic image modalities, laparotomy or autopsy.
Key exclusion criteria
Patients who could not be distinguished from strangulated ileus via laparotomy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Haga |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Departemt of Surgery
Zip code
Address
1-5 Ninomaru, Kumamoto 860-0008, Japan
TEL
096-353-6501
yoshio@kumamed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Haga |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Departemt of Surgery
Zip code
Address
1-5Ninomaru, Kumamoto, Japan
TEL
096-353-6501
Homepage URL
yoshio@kumamed.jp
Sponsor or person
Institute
National Hospital Organization Kumamoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
| 2008 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://poppy.ac/nho/img/summary/eramij_summary2.html
Publication of results
Published
Result
URL related to results and publications
http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ArtikelNr=219367&Ausgabe=249595&ProduktNr=223838
Number of participants that the trial has enrolled
Results
Objective: Acute mesenteric ischemia is potentially fatal, but prognostic factors have not yet been established. This study was undertaken to elucidate them.
Methods: This is a retrospective cohort study, consisting of 110 patients who had been treated in the past 5 years, from 26 national hospitals in Japan.
Results: The overall in-hospital mortality rate was 51%. Logistic regression analysis demonstrated two independent prognostic factors, electrocardiogram scale with an odds ratio of 1.7 (95% CI 1.2-2.4) and shock index of 11 (95% CI 1.5-80). A stepwise analysis gave a prediction equation for in-hospital mortality (R) using these variables and age score. We further modified this equation to a simpler scoring system (S) using the same variables. Both R and S showed a good discriminatory ability as determined by areas under the receiver-operating characteristic curve (0.83, 95% CI 0.74-0.91 for R; 0.82, 95% CI 0.74-0.91 for S). The observed mortality rates increased as the R or S increased (19% at R <0.25, 41% at R values of 0.25 to <0.6, 85% at R values of 0.6 or more; 19% at S of 2 or less, 37% at S of 3 or 4, 91% at S of 5 or more).
Conclusion: The new prediction rules can be used at any hospital and may be promising tools for medical decision-making, informed consent and reviewing quality of care.
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
| 2007 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 09 | Month | 01 | Day |
Other
Other related information
Publication
Haga Y, Odo M, Homma M, Komiyama K, Takeda K, Koike S, Takahashi T, Hiraka K, Yamashita H, Tanakaya K: New prediction rule for mortality in acute mesenteric ischemia. Digestion, 2009;80(2):104-111.
Oral presentation
The 43rd World Congress of the International Society of Surgery (ISS), Sep 8, 2009 Adelaide, Australia, Haga Y, Odo M, Homma M, Komiya K, Takeda K, Koike S, Take-shita T, Hiraka K: New prediction rule for mortality in acute mesenteric ischemia.
Management information
Registered date
| 2008 | Year | 10 | Month | 01 | Day |
Last modified on
| 2015 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001712
| 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 |
