UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000524
Receipt No. R000000635
Scientific Title Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Date of disclosure of the study information 2006/11/17
Last modified on 2017/05/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Acronym Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Scientific Title Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Scientific Title:Acronym Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Region
Japan

Condition
Condition Acute respiratory failure caused by sever pneumonia
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effects of sivelestat sodium in sever pneumonia and acute respiratory failure receiving NPPV
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Duration of ventilatiory assistance, need for endotracheal intubation and mechanical ventilation
Key secondary outcomes PaO2/FiO2 ratio, in-hospital survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control (usual therapy) group: Initial antibiotic administration following the JRS/ATS/IDSA guidelines, and later adjusted to the results of bacterial culture results and antibiogram. Non invasive positive pressure ventilation following the JRS guideline, and oxygen administration adjusted to achieve a level of arterial oxygen saturation above 90%. Bronchodilator therapy and chest physiotherapy as needed and tolerated.
Interventions/Control_2 Intervention group: usual therapy plus intravenous administration of sivelestat sodium.
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 Sever pneumonia and acute respiratory failure receiving NPPV
Key exclusion criteria Respiratory arrest, respiratory pause with loss of consciousness, sever hemodynamic instability
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Kobayashi
Organization Ishinomaki Red Cross Hospital
Division name Department of Respiratory Medicine
Zip code
Address Nishimichishita 71, Hebita, Ishinomaki, Miyagi
TEL 0225-21-7220
Email skoba-thk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichi Kobayashi
Organization Ishinomaki Red Cross Hospital
Division name Department of Respiratory Medicine
Zip code
Address Nishimichishita 71, Hebita, Ishinomaki, Miyagi
TEL 0225-21-7220
Homepage URL
Email skoba-thk@umin.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Ishinomaki Red Cross Hospital
Institute
Department

Funding Source
Organization None
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
2006 Year 11 Month 17 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 Terminated
Date of protocol fixation
2006 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 09 Day
Last follow-up date
2008 Year 10 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 11 Month 17 Day
Last modified on
2017 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.