UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006598 |
|---|---|
| Receipt number | R000007808 |
| Scientific Title | Sivelestat attenuates perioperative inflammatory response in pediatric heart surgery with cardiopulmonary bypass |
| Date of disclosure of the study information | 2011/10/24 |
| Last modified on | 2011/10/24 02:14:31 |
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Basic information
Public title
Sivelestat attenuates perioperative inflammatory response in pediatric heart surgery with cardiopulmonary bypass
Acronym
Sivelestat attenuates perioperative inflammatory response in pediatric heart surgery with cardiopulmonary bypass:
A prospective randomized study
Scientific Title
Sivelestat attenuates perioperative inflammatory response in pediatric heart surgery with cardiopulmonary bypass
Scientific Title:Acronym
Sivelestat attenuates perioperative inflammatory response in pediatric heart surgery with cardiopulmonary bypass:
A prospective randomized study
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of sivelestat for perioperative inflammatory response in pediatric heart surgery with cardiopulmonary bypass
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
white blood cell, neutrophil, polymorphonuclear elastase, C-reactive protein, interleukin-6, interleukin-8, tumor necrosis factor alpha
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The sivelestat group patients are administrated continuous intravenous infusion of 0.2mg/kg/h of sivelestat, and the control group patients are administrated same volume of 0.9% saline at the initiation of CPB to 24h after surgery.
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
consecutive heart surgery with cardiopulmonary bypass,
patients are weighting between 5 to 10 kg with
Key exclusion criteria
patients with chromosome aberration were excluded
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Inoue |
Organization
Kitasato university shcool of medicine
Division name
cardiovascular surgery
Zip code
Address
Kitasato 1-15-1, Minami, Sagamihara 252-0329, Japan
TEL
042-778-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato university shcool of medicine
Division name
cardiovascular surgery
Zip code
Address
TEL
Homepage URL
nobuyuki-i@goo.jp
Sponsor or person
Institute
kitasato university school of medicine
Institute
Department
Personal name
Funding Source
Organization
department of cardiovascular surgery, kitasato university school of medicine
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
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
| 2011 | Year | 10 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
Management information
Registered date
| 2011 | Year | 10 | Month | 24 | Day |
Last modified on
| 2011 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007808
