UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040754
Receipt number 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 19:43:38

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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 or person

Institute

Shinshu University Hospital

Institute

Department

Personal name



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

Value
https://center6.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