UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041276 |
|---|---|
| Receipt number | R000047140 |
| Scientific Title | Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2025/02/05 16:37:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Acronym
Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Scientific Title
Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Scientific Title:Acronym
Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Region
| Japan |
Condition
Condition
Adult coronavIrus disease 2019 patients discharged from the intensive care unit who were able to walk on their own without assistance prior to infection.
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of post-intensive care syndrome in patients with severe COVID-19.
Basic objectives2
Others
Basic objectives -Others
To investigate the incidence of post-intensive care syndrome in patients with severe COVID-19.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short-Memory Questionnaire (SMQ), Barthel Index, Hospital Anxiety and Depression Scale (HADS), and visual analogue scale such as EuroQol 5 Dimension (EQ-5D)-5L and EQ-5D-VAS by questionnaire at 6, 12, and 24 months after ICU 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
Adult COVID19 patients leaving the intensive care unit between March 2020 and March 2021
Key exclusion criteria
Patients unable to walk on their own before SARS-CoV-2 infection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Hatakeyama |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
152-8902
Address
2-5-1, Higashigaoka Meguro-ku, Tokyo
TEL
03-3411-0111
hatakeyama-jik@umin.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Hatakeyama |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
152-8902
Address
2-5-1, Higashigaoka Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
hatakeyama-jik@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nestle Health Science
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo Medical Center
Address
2-5-1, Higashigaoka Meguro-ku, Tokyo
Tel
03-3411-0111
hatakeyama-jik@umin.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2077-0383/11/19/5758
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/11/19/5758
Number of participants that the trial has enrolled
410
Results
The first and second PICS surveys were obtained at 5.5 and 13.5 months (mean) after ICU discharge, with 251 and 209 patients completing the questionnaires and with a prevalence of PICS of 58.6% and 60.8%, respectively, along with the highest percentages of cognitive impairment. Delirium and the duration of mechanical ventilation were independently identified as the risk factors for PICS in the first PICS survey.
Results date posted
| 2024 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The PICS survey was conducted among patients discharged from the ICU between March and December 2020. The inclusion criteria for this study included patients with COVID-19 aged >= 20 years who required invasive mechanical ventilation during hospitalization. The indications for invasive mechanical ventilation management were determined at the discretion of the participating institutions. A SARS-CoV-2 infection was confirmed using a polymerase chain reaction test. The exclusion criteria comprised patients from whom written informed consent could not be obtained; and patients who were unable to walk on their own before admission, regardless of the use of assistive devices, because of the possibility of pre-existing PICS. All patients with COVID-19 who require mechanical ventilation are promptly registered in the CRISIS registry in accordance with the national policy when they are admitted to the ICUs of each participating institution. The patients registered in the CRISIS registry were enrolled in our study if they met the inclusion criteria. Written informed consent was obtained from all patients in the analysis.
Participant flow
Two surveys were conducted to evaluate PICS, with questionnaires sent to patients in February and October 2021. We did not send questionnaires to those who could not be contacted post-discharge. The central office made a phone call prior to sending the first PICS survey. Patients who did not respond to the first questionnaire were not sent a second questionnaire. In the second PICS survey, a phone call was also made prior to sending the questionnaire. The questionnaire consisted of simple questions regarding PICS. The Barthel Index (BI) [22,23], Short-Memory Questionnaire (SMQ) [24], Hospital Anxiety and Depression Scale (HADS)-anxiety, HADS-depression [25], and EQ-5D-5L [26] were used for the assessment of physical function, cognitive function, mental health, and QOL, respectively. Responses provided from someone approved by the patient to act in their place were permitted. All the questionnaire items are listed in the Supplemental Table S2. The responses were collected and tabulated at the central office.
Adverse events
None
Outcome measures
The primary outcome was the prevalence of PICS after an ICU discharge as shown in the first PICS survey. The secondary outcomes were the prevalence of PICS after an ICU discharge as shown in the second PICS survey and the prevalence of three elements in the PICS and answers to all the other questions . The risk factors were analyzed for PICS in terms of the presence of three components, namely, a physical impairment, cognitive impairment, or mental disorder . In this study, PICS was defined as any one of the following functional impairments: a physical impairment was defined as a score of <=90 points on the BI , cognitive impairment as a score of <40 points on the SMQ , and mental disorder as a score of >=8 points on the HADS-anxiety or HADS-depression scale .
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 05 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047140
