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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000042970 |
Receipt No. | R000049056 |
Scientific Title | "The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU". |
Date of disclosure of the study information | 2021/01/12 |
Last modified on | 2021/01/11 |
Basic information | ||
Public title | "The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU". | |
Acronym | "The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU". | |
Scientific Title | "The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU". | |
Scientific Title:Acronym | "The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU". | |
Region |
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Condition | |||
Condition | Patients of ICU | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study was to determine the relationship between the Early Warning Score and Nursing Activities Score at ICU Discharge and ICU Readmission in patients admitted to the ICU for emergencies. |
Basic objectives2 | Others |
Basic objectives -Others | non |
Trial characteristics_1 | Others |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The primary outcome of this study is the association between NEWS and NAS and ICU readmission. |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients aged 18 years or older who were admitted urgently to the ICU in our hospital from April 1, 2011 to December 31, 2019. | |||
Key exclusion criteria | 1) Patients who died in ICU
(2) Patients admitted to ICU for bed control (3) Patients whose vital signs were not monitored when they left ICU 3) Patients whose vital signs were not monitored at the time of ICU discharge. 4) Patients who have been re-admitted to ICU more than three times. |
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Target sample size | 1000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Sapporo Medical University, School of Medicine. | ||||||
Division name | Department of Intensive Care Medicine | ||||||
Zip code | 060-8543 | ||||||
Address | South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan | ||||||
TEL | 011-611-2111 | ||||||
jp.haruna@hotmail.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Sapporo Medical University, School of Medicine. | ||||||
Division name | Department of Intensive Care Medicine | ||||||
Zip code | 060-8543 | ||||||
Address | South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan | ||||||
TEL | 0116112111 | ||||||
Homepage URL | |||||||
jp.haruna@hotmail.co.jp |
Sponsor | |
Institute | Sapporo Medical University |
Institute | |
Department |
Funding Source | |
Organization | Sapporo Medical 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 | Sapporo medical University |
Address | South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan |
Tel | 011-611-2111 |
jp.haruna@icloud.com |
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 | |
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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | non |
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=R000049056 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |