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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032877
Receipt No. R000037489
Official scientific title of the study The effect of zinc supplementation in the sepsis patients
Date of disclosure of the study information 2018/06/06
Last modified on 2018/06/05

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Basic information
Official scientific title of the study The effect of zinc supplementation in the sepsis patients
Title of the study (Brief title) Zinc and sepsis
Region
Japan

Condition
Condition Sepsis
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is that zinc supplementation in the sepsis patients contributes the mortality, coagulopathy or DIC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The improvement of DIC score in 7th day after admission
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation YES
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 The administration of NOBELZIN 50mg 100mg/day for 7 days at least
Interventions/Control_2 The none of administration
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
100 years-old >
Gender Male and Female
Key inclusion criteria The sepsis patients using Sepsis-3 criteria
The patients living over 48 hours
The patients can get tube feeding or oral feeding within 48 hours after admission
The patients within 72 hours after admission
The serum zinc below 60 ug/dL within 48 hours after admission
Key exclusion criteria cardiopulmonary arrest on arrival
dialyzed patient
liver cirrhosis patients
pregnant female
cardiogenic shock patients
cancer bearing patients
Target sample size 40

Research contact person
Name of lead principal investigator Yuhei Irie
Organization Fukuoka university hospital
Division name The department of emergency and critical care
Address 7-45-1 Nanakuma Johnan-ku Fukuoka city
TEL 092-801-1011
Email iriey@fukuoka-u.ac.jp

Public contact
Name of contact person Yuhei Irie
Organization Fukuoka university hospital
Division name The department of emergency and critical care
Address 7-45-1 Nanakuma Johnan-ku Fukuoka city
TEL 092-801-1011
Homepage URL
Email iriey@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka university
Institute
Department

Funding Source
Organization Fukuoka university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 06 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 06 Day
Anticipated trial start date
2018 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 05 Day
Last modified on
2018 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037489

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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