UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036507
Receipt No. 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 (Ver. 1)

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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
Last 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
Email mfujii-cvs@umin.ac.jp

Public contact
1st 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
Email mfujii-cvs@umin.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041560