- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04921085
Nutritional Status Study of Inpatients in Hospitals
July 17, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
evaluating the nutritional status of inpatients with 7 catogories of diseases ( including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, urinary system) within 24~48 hours after admission.
Among them, the Second Affiliated Hospital of Zhejiang University School of Medicine has undertaken 200 cases, and a total of 25 hospitals in zhejiang participated(5000 cases in total).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adult inpatients with within 7 categories of diseases (including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, and urinary system)
Description
Inclusion Criteria:
- Inpatients with 7 categories of diseases (including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, and urinary system)
- Age ≥ 18
- 24~48h after admission
Exclusion Criteria:
- Age<18
- Critically ill patient
- With mental illness and cannot think or behavior normally
- Any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
adult inpatients
adult inpatients with 7 categories of diseases (including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, and urinary system)
|
Cross-sectional obeservational survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional risk screening scored with NRS 2002 questionnaire
Time Frame: 24~48 hours after admission
|
Detect the presence of undernutrition and the risk of developing undernutrition by Risk Screening 2002 questionnaire(NRS-2002) .
The overall score range is from 0 to 7, when score≥3, the patient is nutritionally at-risk
|
24~48 hours after admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body fat mass
Time Frame: 24~48 hours after admission
|
Body Fat Mass is assessed by bioelectrical impedance analysis (BIA)
|
24~48 hours after admission
|
Body muscle mass
Time Frame: 24~48 hours after admission
|
Body muscle mass is assessed by bioelectrical impedance analysis (BIA)
|
24~48 hours after admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
March 30, 2021
Study Completion (Actual)
March 30, 2021
Study Registration Dates
First Submitted
May 31, 2021
First Submitted That Met QC Criteria
June 9, 2021
First Posted (Actual)
June 10, 2021
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 17, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2020-928
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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