UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013188 |
|---|---|
| Receipt number | R000015377 |
| Scientific Title | Study of the preventive effect of the sivelestat sodium hydrate for respiratory complications in high-risk patients underwent upper abdominal surgery |
| Date of disclosure of the study information | 2014/02/18 |
| Last modified on | 2014/02/18 12:13:51 |
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Basic information
Public title
Study of the preventive effect of the sivelestat sodium hydrate for respiratory complications in high-risk patients underwent upper abdominal surgery
Acronym
Preventive effect of sivelestat sodium hydrate for respiratory complications in patients underwent upper abdominal surgery
Scientific Title
Study of the preventive effect of the sivelestat sodium hydrate for respiratory complications in high-risk patients underwent upper abdominal surgery
Scientific Title:Acronym
Preventive effect of sivelestat sodium hydrate for respiratory complications in patients underwent upper abdominal surgery
Region
| Japan |
Condition
Condition
Upper abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the preventive effect of the sivelestat sodium hydrate for respiratory complications in high-risk patients underwent upper abdominal surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative respiratory complications
Key secondary outcomes
1) The frequency of occurrence of postoperative complications
2) Duration of postoperative SIRS
3) Postoperative hospital stay
4) Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
| Medicine |
Interventions/Control_1
Perioperative administration of sivelestat sodium hydrate
Interventions/Control_2
control
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who are scheduled for (stomach, liver, biliary tract, pancreas) upper abdominal surgery
2) Patients with high probability of postoperative respiratory complications (RFRI> 28 point)
3) Patient with written informed consent
Key exclusion criteria
1) Patients who is not expected curative resection
2) Patients with active infection
3) Patients with a history of drug hypersensitivity to sivelestat sodium hydrate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachio Fushida |
Organization
Kanazawa University
Division name
Gastroenterologic Surgery
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2000
oya-ma@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsunobu Oyama |
Organization
Kanazawa University
Division name
Gastroenterologic Surgery
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2000
Homepage URL
oya-ma@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Gastroenterologic Surgery, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Support Organization (DDSO)
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
| 2014 | Year | 02 | Month | 18 | 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
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 18 | 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 | 02 | Month | 18 | Day |
Last modified on
| 2014 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015377
