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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040754
Receipt No. R000046531
Scientific Title Examination of early rehabilitation effect in an emergency center and intensive care unit in patients with sepsis: A Prospective Multicenter Cohort Study
Date of disclosure of the study information 2020/06/14
Last modified on 2020/06/13

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Basic information
Public title Examination of early rehabilitation effect in an emergency center and intensive care unit in patients with sepsis: A Prospective Multicenter Cohort Study
Acronym Examination of early rehabilitation effect in patients with sepsis: A Prospective Multicenter Cohort Study
Scientific Title Examination of early rehabilitation effect in an emergency center and intensive care unit in patients with sepsis: A Prospective Multicenter Cohort Study
Scientific Title:Acronym Examination of early rehabilitation effect in patients with sepsis: A Prospective Multicenter Cohort Study
Region
Japan

Condition
Condition Sepsis
Septic shock
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of early rehabilitation in patients with sepsis by a multicenter study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ADL using the Barthel index. Barthel index (BI) is evaluated by physical therapist at discharge from hospital.
Key secondary outcomes Onset of pulmonary complications and delirium, length of hospital stay, cost-effectiveness, discharge outcome.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects of this study were sepsis patients who entered the emergency center and intensive care unit between April 2020 and September 2023.
Key exclusion criteria Patients with head injuries, burns, spinal injuries, lower limbs with multiple fractures, and those with septic shock who are unresponsive to maximal treatment, moribund or had an expect mortality within 48 h.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Yasunari
Middle name
Last name Sakai
Organization Shinshu University Hospital
Division name Rehabilitation
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto-shi, Nagano
TEL 0263-37-2836
Email yasunari_sakai1028@yahoo.co.jp

Public contact
Name of contact person
1st name Yasunari
Middle name
Last name Sakai
Organization Shinshu University Hospital
Division name Rehabilitation
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto-shi, Nagano
TEL 0263-37-2836
Homepage URL
Email yasunari_sakai1028@yahoo.co.jp

Sponsor
Institute Shinshu University Hospital
Institute
Department

Funding Source
Organization Shinshu University.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Aizawa Hospital
Ina Central Hospital
Saku Central Hospital Advanced Care Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shinshu University
Address 3-1-1 Asahi, Matsumoto-shi, Nagano
Tel 0263-37-2572
Email mdrinri@shinshu-u.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 信州大学医学部附属病院(長野県)
社会医療法人財団 相澤病院(長野県)
伊那中央病院(長野県)
JA長野厚生連 佐久医療センター(長野県)

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 14 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 800
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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 12 Day
Date of IRB
2019 Year 11 Month 12 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2023 Year 09 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participant age, sex, body mass index (BMI), sequential organ failure assessment (SOFA) score, systemic inflammatory response syndrome (SIRS) score, disseminated intravascular coagulation (DIC) score, laboratory data (procalcitonin), primary source of infection, use of therapeutic medication, use of mechanical ventilation, BI baseline and discharge, length of hospital stay, patients discharge outcome, cost-effectiveand, onset of plmonary complications and delirium, the number of days until rehabilitation are recorded.

Management information
Registered date
2020 Year 06 Month 13 Day
Last modified on
2020 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046531

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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