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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006598
Receipt No. 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

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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
Email

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
Email nobuyuki-i@goo.jp

Sponsor
Institute kitasato university school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007808

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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