UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034072
Receipt number R000038564
Scientific Title Practice patterns and the prevalence of postintensive care syndrome in Japanese intensive care unit: a prospective multicenter study
Date of disclosure of the study information 2018/10/26
Last modified on 2021/02/22 09:28:43

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Basic information

Public title

Practice patterns and the prevalence of postintensive care syndrome in Japanese intensive care unit: a prospective multicenter study

Acronym

Practice patterns and the prevalence of postintensive care syndrome in Japanese intensive care unit: a prospective multicenter study (the J-PICS study)

Scientific Title

Practice patterns and the prevalence of postintensive care syndrome in Japanese intensive care unit: a prospective multicenter study

Scientific Title:Acronym

Practice patterns and the prevalence of postintensive care syndrome in Japanese intensive care unit: a prospective multicenter study (the J-PICS study)

Region

Japan


Condition

Condition

Critically ill patients who are expected to undergo mechanical ventilation for more than 48 hours.

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examined practice patterns and prevalence of postintensive care unit in Japanese intensive care units.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

prevalence of PICS and PICS-F.

Key secondary outcomes

6-month mortality, ICU length of stay, Hospital length of stay, delirium-free and coma-free days (DFCFDs), ventilator free days (VFD)


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

Critically ill patients required mechanical ventilation for more than 48 hours.

Key exclusion criteria

Dementia, patients who had a proven or suspected acute primary brain process that was likely to result in global impairment of consciousness or cognition, patients who recieved mechanical ventilation before admission, patients who receive palliative care. We excluded data from any second or subsequent readmission to ICU during the index hospital admission. Patients who have no surrogates, patients who did not speak Japanese, patients for whom follow-up would be difficult. Patients who opt-outed of this study

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Kawakami

Organization

Kobe City Medical Center General Hospital

Division name

department of anesthesiology

Zip code

650-0047

Address

2-1-1, Minatajima-minami machi, Chuo-ku, Kobe City, Hyogo Prefecture, Japan

TEL

078-302-4321

Email

dsk_kwkm_n9s@hotmail.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Kawakami

Organization

Kobe City Medical Center General Hospital

Division name

department of anesthesiology

Zip code

650-0047

Address

2-1-1, Minatajima-minami machi, Chuo-ku, Kobe City, Hyogo Prefecture, Japan

TEL

078-302-4321

Homepage URL


Email

dsk_kwkm_n9s@hotmail.co.jp


Sponsor or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



Funding Source

Organization

Kobe City Medical Center General Hospital

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

Kobe City Medical Center General Hospital

Address

2-1-1, Minatajima-minami machi, Chuo-ku, Kobe City, Hyogo Prefecture, Japan

Tel

078-302-4321

Email

rinken@kcho.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

2018 Year 10 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

192

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

Main results already published

Date of protocol fixation

2018 Year 10 Month 26 Day

Date of IRB

2018 Year 09 Month 27 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1) Patients demographics
We will collect information on age, sex, heights, weights, years of education, marital status, work status, type of residence, preexisting cognitive impairment according to short memory questionnaire (SMQ), 36-Item Short Form Health Survey (SF-36v2), Clinical Frailty Scare, DNAR code status, the day for hospital admission, the day for ICU admission, route of ICU admission, reasons for ICU admission (surgical and non-surgical, emergency or planed, emergency code or RRT (rapid response team) or MET (medical emergency team)), admission diagnosis (cardiovascular, respiratory failure, sepsis, trauma, others), operative procedure, diagnosis of ARDS (acute respiratory distress syndrome), sepsis, preadmission medication (benzodiazepine or steroid), Charlson comorbidity index, Acute Physiology and Chronic Health Evaluation (APACHE) II score and SOFA (sequential organ failure assessment) score.

2) Daily data
We will collect the daily data at 8:00 am from ICU admission to ICU day 4 or ICU discharge. The daily data include the use of catecholamine, steroid, analgesic agents, sedative drugs, sleep agents, antipsychotic agents, neuromuscular blockade. Positive CAM-ICU test, presence of RASS -4 or -5, check list of ABCDEFGH bundle compliance, the use of restraint.

3) Outcome data at hospital discharge
We will collect the data of ICU discharge date, withdrawing and withholding life-sustaining therapies in ICU, initiation of renal replacement therapy in ICU, the use of IABP or ECMO, the length of mechanical ventilation, diagnosis of ICUAW, the hospital discharge date.

4) Outcome data at 6 months after ICU admission
We will collect information on marital status, work status, type of residence, SF-36v2, SMQ, HADS (family), IWES-R (family), Global rating of change questionnaires for assessing MID (Minimally importance difference).


Management information

Registered date

2018 Year 09 Month 10 Day

Last modified on

2021 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038564


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name