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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042607 |
Receipt No. | R000048553 |
Scientific Title | Survey of nutritional management for patients in the ICU and association between prescribed doses of nutrients during fasting period and clinical outcomes in the long-term fasting patients in the ICU : A cohort study using a medical claims database |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2020/11/26 |
Basic information | ||
Public title | Survey of nutritional management for patients in the ICU and association between prescribed doses of nutrients and clinical outcomes in the long-term fasting patients in the ICU : A cohort study using a medical claims database | |
Acronym | Nutritional management and clinical outcomes in the ICU | |
Scientific Title | Survey of nutritional management for patients in the ICU and association between prescribed doses of nutrients during fasting period and clinical outcomes in the long-term fasting patients in the ICU : A cohort study using a medical claims database | |
Scientific Title:Acronym | Nutritional management and clinical outcomes in the ICU | |
Region |
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Condition | ||
Condition | Patients with mechanical ventilation in the ICU | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | (1) To clarify nutritional management for patients in the ICU
(2) To investigate the association between prescribed doses of nutrients and clinical outcomes in fasting patients over 7 days after admission to the ICU |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | In-hospital mortality |
Key secondary outcomes | (1)Length of hospital stay
(2)Readmission |
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 | |
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Eligibility | ||||
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1)Patients admitted to the ICU between January 1, 2010 and June 30, 2020
(2)Patients aged 18 years or older (3)Patients with mechanical ventilation on both 1st and 2nd day in the ICU (4)Patients in the ICU 3 days or more |
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Key exclusion criteria | (1)Patients who died or were discharged within 7 days in the ICU
(2)Patients who received oral feeding within 2 days in the ICU (3)Patients whose height is less than 100 cm or 200 cm or more (4)Patients whose body weight is less than 10 kg or 200 kg or more (5)Patients whose body weight or height data is missing |
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Target sample size | 40000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Jichi Medical University Saitama Medical Center | ||||||
Division name | Emergency Department | ||||||
Zip code | 330-8503 | ||||||
Address | 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama | ||||||
TEL | 048-647-2111 | ||||||
yasudahideto@me.com |
Public contact | |||||||
Name of contact person |
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Organization | Otsuka Pharmaceutical Factory, Inc. | ||||||
Division name | Medical Affairs Department | ||||||
Zip code | 101-0048 | ||||||
Address | 2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo | ||||||
TEL | 03-5217-5954 | ||||||
Homepage URL | |||||||
Horikoshi.Yuri@otsuka.jp |
Sponsor | |
Institute | Jichi Medical University Saitama Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Otsuka Pharmaceutical Factory, Inc. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Otsuka Pharmaceutical Factory, Inc. |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Jichi Medical University Bioethics Committee for Clinical Research, Saitama Medical Center |
Address | 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama |
Tel | 048-647-2111(2367) |
s-suishin@jichi.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 |
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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 | |
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Baseline Characteristics | |
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Outcome measures | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
Other related information | Study design
A cohort study using the medical claims database Data source A medical database provided by Medical Data Vision Co. Ltd. The database is based on the DPC data/medical claims database. The database covers about 23% of all DPC hospitals in Japan. All data is anonymized from the viewpoint of personal information protection. Survey of nutritional management The nutritional management is surveyed based on the prescription and treatment records available in the database. We analyze day of initiation of EN, route of nutritional administration, prescribed dose of parenteral nutrition, and risk factors for long-term fasting. Association between prescribed doses of nutrients and clinical outcomes during fasting period Patients who are fasting over 7 days are divided into two groups based on the prescribed doses of nutrients between 4-7 days. To examine the association between prescribed doses of nutrients and clinical outcomes, multivariable logistic regression analysis adjusting for patient characteristics as confounding factors is performed, and odds ratios and the 95% confidence intervals are estimated. |
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=R000048553 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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