UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049683 |
|---|---|
| Receipt number | R000056589 |
| Scientific Title | Post-intensive care syndrome outpatient: a scoping review |
| Date of disclosure of the study information | 2022/12/04 |
| Last modified on | 2024/05/14 14:14:23 |
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Basic information
Public title
Post-intensive care syndrome outpatient: a scoping review
Acronym
Post-intensive care syndrome outpatient: a scoping review
Scientific Title
Post-intensive care syndrome outpatient: a scoping review
Scientific Title:Acronym
Post-intensive care syndrome outpatient: a scoping review
Region
| Japan |
Condition
Condition
Post-intensive care syndrome
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate ambulatory methods of assessing long-term prognosis of patients leaving the intensive care unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
When, who, where, and using what methods to assess for post-intensive care syndrome.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients who received intensive care in the ICU and who were discharged from the ICU for an outpatient visit for a PICS-related consultation (in addition to treatment of the primary illness for which they were treated).
Key exclusion criteria
reviw, protocol, trial resisgry, case report, conference abstract, and study based on other language than English
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | HATAKEYAMA |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
junji.hatakeyama@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | HATAKEYAMA |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
junji.hatakeyama@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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
| 2022 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00540-024-03326-4
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00540-024-03326-4
Number of participants that the trial has enrolled
12
Results
Twelve papers discussed ICU follow-up clinics. These clinics were mainly led by doctors or nurses, but also involved pharmacists, physiotherapists, neuropsychologists and social workers. Some clinics were restricted to patients with severe sepsis or those requiring ventilation; 10 studies reported that the first outpatient visit was one to three months after discharge. All studies assessed physical function, cognitive function, mental health and health-related quality of life.
Results date posted
| 2024 | Year | 05 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Studies with follow-up outpatient clinic after ICU discharge
Participant flow
Studies with follow-up outpatient clinic after ICU discharge
Adverse events
None
Outcome measures
A scoping review was conducted of existing ICU follow-up practice methodologies up to December 2022. Data were examined for country or region, outpatient name, location, opening date, lead occupation, target patients, timing of follow-up and assessment tools 12 studies were included in the review. The results revealed that the methods employed by ICU follow-up clinics varied between countries and regions. The names of the outpatient follow-up clinics varied, but all were located within the institution. These clinics were mainly led by a doctor or nurse, but also involved pharmacists, physiotherapists, neuropsychologists and social workers. Some clinics were restricted to patients with severe sepsis or those requiring ventilation; 10 studies reported that the first outpatient visit was one to three months after discharge. All studies assessed physical function, cognitive function, mental health and health-related quality of life. This scoping review highlights the need to establish the optimal mode of operation of ICU follow-up clinics, depending on the category of critically ill patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No ethical committee due to the scoping review
Management information
Registered date
| 2022 | Year | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056589
