UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042272
Receipt number R000048219
Scientific Title Post intensive care syndrome in critically ill patients: An observational study
Date of disclosure of the study information 2020/10/28
Last modified on 2020/10/28 17:19:41

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Basic information

Public title

Post intensive care syndrome in critically ill patients: An observational study

Acronym

Post intensive care syndrome in critically ill patients: An observational study

Scientific Title

Post intensive care syndrome in critically ill patients: An observational study

Scientific Title:Acronym

Post intensive care syndrome in critically ill patients: An observational study

Region

Japan


Condition

Condition

1. sepsis, 2. resuscitation from out-of-hospital cardiac arrest, 3. severe burn, and 4. trauma

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify long-term physical, cognitive and mental function, the activity of daily living, and quality of life (post-ICU syndrome) in critically ill patients after the discharge of the intensive care unit.

Basic objectives2

Others

Basic objectives -Others

Descriptive

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1). Short Form-36
2). Euro QOL
3). Mini Mental State Examination (MMSE)
4). Hospital Anxiety and Depression Scale (HADS) and K6 for emotional disorder and anxiety
until two years of hospital discharge (at 6, 12, 18, and 24 months after discharge).

Key secondary outcomes



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

1. The patients with sepsis, resuscitated out-of-hospital cardiac arrest, severe burn, or trauma admitted to the intensive care unit of Tohoku University Hospital.
2. These patients who are survived at discharge and expected to be independent or slight disability at home and come to the outpatient.

Key exclusion criteria

1. Less than 18 years old
2. Not severe patients
3. Patients who are not survived at discharge
4. The patients who are not able to come outpatient because of moderate or severe disability
5. The patients who are not able to come to the outpatient within one year after discharge for any reason.
6. The patients who died within one year after discharge.
7. The patients who do not consent to participate in the study
8. The patients whom the attending physician decided not to enroll in the study for the other reasons

Target sample size

145


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Kudo

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Emergency and Critical Care Medicine

Zip code

9808574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

0227177489

Email

kudodaisuke@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Kudo

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Emergency and Critical Care Medicine

Zip code

9808574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

0227177489

Homepage URL


Email

information@emergency-medicine.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



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

Ethics Committee Tohoku University Graduate School of Medicine

Address

2-1 Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 28 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

Enrolling by invitation

Date of protocol fixation

2019 Year 09 Month 16 Day

Date of IRB

2019 Year 11 Month 25 Day

Anticipated trial start date

2021 Year 01 Month 01 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a single-center observational study.


Management information

Registered date

2020 Year 10 Month 28 Day

Last modified on

2020 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048219


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name