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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016871 |
Receipt No. | R000019583 |
Scientific Title | Current Status of Nutritional Practice In Japan: A Multicenter Observational Study |
Date of disclosure of the study information | 2015/03/25 |
Last modified on | 2018/12/15 |
Basic information | ||
Public title | Current Status of Nutritional Practice In Japan: A Multicenter Observational Study | |
Acronym | ICU-PRO study | |
Scientific Title | Current Status of Nutritional Practice In Japan: A Multicenter Observational Study | |
Scientific Title:Acronym | ICU-PRO study | |
Region |
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Condition | ||
Condition | Patients who receive mechanical ventilation for at least 24 hours and are in the ICU for longer than 72 hours | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | 1. To assess current status of nutritional practice in Japanese intensive care units.
2. To assess the relationship between amino acid and protein intakes and outcomes in patients with critical illnesses. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Rehabilitation status on day of discharge from the intensive care unit. |
Key secondary outcomes | 28 days mortality |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who receive mechanical ventilation for at least 24 hours and are in the ICU for longer than 72 hours. | |||
Key exclusion criteria | Patients who ask us not to use their clinical information. | |||
Target sample size | 360 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kochi Medical School | ||||||
Division name | Department of Anesthesiology and Intensive Care Medicine | ||||||
Zip code | |||||||
Address | Kohasu, Oko-cho, Nankoku, Kochi, Japan | ||||||
TEL | 088-880-2471(+81-88-880-2471) | ||||||
yatabe@kochi-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kochi Medical School | ||||||
Division name | Department of Anesthesiology and Intensive Care Medicine | ||||||
Zip code | |||||||
Address | Kohasu, Oko-cho, Nankoku, Kochi, Japan | ||||||
TEL | 088-880-2471(+81-88-880-2471) | ||||||
Homepage URL | |||||||
yatabe@kochi-u.ac.jp |
Sponsor | |
Institute | Kochi Medical School |
Institute | |
Department |
Funding Source | |
Organization | Kochi University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) | JSPS KAKENHI
Grant-in-Aid for Scientific Research(C) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/30541003 |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | 1)Age,gender,height,weight
2)The day for ICU admission and discharge 3)Reasons for ICU admission 4)The status(dead or alive) at 28 days after ICU admission. 5)APACHE II and SOFA score 6)Type and amount of nutrition received on ICU day 3,day 7, and day of discharge from the ICU. 7)Free-ventilator day during 28 days, length of ICU and hospital stays, mortality, and rehabilitation status. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019583 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |