UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036507 |
|---|---|
| Receipt number | R000041560 |
| Scientific Title | Effect of sivelestat, a neutrophil elastase inhibitor on cardiac surgical patients after cardiopulmonary bypass |
| Date of disclosure of the study information | 2019/04/14 |
| Last modified on | 2019/04/14 23:10:55 |
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Basic information
Public title
Effect of sivelestat, a neutrophil elastase inhibitor on cardiac surgical patients after cardiopulmonary bypass
Acronym
Effect of sivelestat, a neutrophil elastase inhibitor on cardiac surgical patients after cardiopulmonary bypass
Scientific Title
Effect of sivelestat, a neutrophil elastase inhibitor on cardiac surgical patients after cardiopulmonary bypass
Scientific Title:Acronym
Effect of sivelestat, a neutrophil elastase inhibitor on cardiac surgical patients after cardiopulmonary bypass
Region
| Japan |
Condition
Condition
cardiac and aortic disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of sivelestat administration in cardiac surgical patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
perioperative cytokine in bronchial bronchiolar lavage fluid, pulmonary function, oxygenation.
Key secondary outcomes
myocardial injury, hemodynamics, perioperative cytokine in blood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.9 % saline 2ml/hr for 24 hours
Interventions/Control_2
sivelestat 0.2mg/kg/hr for 24 hours
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
cardiac surgical patients undergoing cardiopulmonary bypass
Key exclusion criteria
shock, pulmonary edema, liver dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon Medical School
Division name
Cardiovascular surgery
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo, Tokyo
TEL
03-3822-2131
mfujii-cvs@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon Medical School
Division name
Cardiovascular surgery
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo, Tokyo
TEL
03-3822-2131
Homepage URL
mfujii-cvs@umin.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
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
03-3822-2131
Address
1-1-5 Sendagi, Bunkyo, Tokyo
Tel
03-3822-2131
mfujii-cvs@umin.ac.jp
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
| 2019 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
DOI: 10.1510/icvts.2009.225243
Publication of results
Partially published
Result
URL related to results and publications
DOI: 10.1510/icvts.2009.225243
Number of participants that the trial has enrolled
30
Results
In the control group, the levels of PMN elastase, IL-6, IL-8 in BAL showed a increase after CPB initiation, and were maintained at high levels 3 hours after CPB. In contrast, the sivelestat group had lower concentrations of PMN elastase, IL-6, IL-8 during and after CPB.
The reduction in PaO2/FiO2 ratio after CPB was strongly related to the increase in IL-8, IL-6 or the elevation in PMN elastase.
Results date posted
| 2019 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2010 | Year | 03 | Month | 30 | Day |
Baseline Characteristics
Control
age 65
gender M 8/F 7
VHD 11
VHD+IHD 4
Sivelestat
age 68
gender M 6/F 9
VHD 9
VHD+IHD 4
Cardiac tumor 1
TAA 1
Participant flow
Main outcome:
Control　 AVR 6 cases
Sivelestat　AVR 6 cases
Adverse events
none
Outcome measures
PMN elastase in BAL
during CPB post CPB
control 477 666
sivelestat 78 204 *p=0.0002
IL-6 in BAL
during CPB post CPB
control 6521 8913
sivelestat 456 3549 *p=0.029
IL-8 in BAL
during CPB post CPB
control 156 124
sivelestat 120 43 *p=0.527
P/F post CPB 3h 12h
control 33 43
sivelestat 11 17 *p=0.0086
Plan to share IPD
NO
IPD sharing Plan description
NO
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2004 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2004 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2004 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2005 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 14 | Day |
Last modified on
| 2019 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041560
