UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039995
Receipt number R000045601
Scientific Title The effect of ICU Diary on the type of memory in the ICU: Multicenter study
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/31 09:55:37

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Basic information

Public title

The effect of ICU Diary on the type of memory in the ICU: Multicenter study

Acronym

The effect of ICU Diary on the type of memory in the ICU: Multicenter study

Scientific Title

The effect of ICU Diary on the type of memory in the ICU: Multicenter study

Scientific Title:Acronym

The effect of ICU Diary on the type of memory in the ICU: Multicenter study

Region

Japan


Condition

Condition

We included patients who mechanical ventilation for at least 48 hours that was initiated within 48 hours of ICU admission.

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the effect of an ICU dairy on ICU survivors, according to the type of memory in an ICU.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome of this study is to assess the rate of change in the IES-R to the type of memory in the ICU.

Key secondary outcomes

The secondary outcomes of this study are the rate of change in HADS and the change in HMGB1 according to the type of memory in the ICU.


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

200 years-old >=

Gender

Male and Female

Key inclusion criteria

We included patients had to be aged at least 18 years, receiving mechanical ventilation for at least 48 hours that was initiated within 48 hours of ICU admission.

Key exclusion criteria

We excluded the following patients:
1)History of apparent central nervous system disease (stroke, head injury, central nervous system infection, brain tumor, after brain surgery, after cardiopulmonary arrest resuscitation, etc.)
2)History of psychiatric disorders / dementia
3)Alcohol and other poisoning patients
4)Neurological disease
5)Hematological tumor diseases
6)Patient who cannot understand Japanese
7)Visually impaired and Hearing impaired
8)Patients admitted to an ICU at a research facility from an ICU at another hospital
9)Patients who are discharged to ICU of another hospital

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Hiroomi
Middle name
Last name Tatsumi

Organization

Sapporo Medical University

Division name

Department of Intensive Care Medicine

Zip code

064-8543

Address

South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan

TEL

+81-11-611-2111

Email

jp.haruna@hotmail.co.jp


Public contact

Name of contact person

1st name JUNPEI
Middle name
Last name HARUNA

Organization

Sapporo Medical University, School of Medicine.

Division name

Department of Intensive Care Medicine

Zip code

064-8543

Address

South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan

TEL

+81-11-611-2111

Homepage URL

http://sapmedicu.com/

Email

jp.haruna@hotmail.co.jp


Sponsor or person

Institute

Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Sapporo medical University

Address

South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan

Tel

+81-11-611-2111

Email

jp.haruna@hotmail.co.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



Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 01 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

Open public recruiting

Date of protocol fixation

2020 Year 03 Month 12 Day

Date of IRB

2020 Year 03 Month 11 Day

Anticipated trial start date

2020 Year 03 Month 12 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Non


Management information

Registered date

2020 Year 03 Month 31 Day

Last modified on

2020 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045601


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name