NutritionNCT04974112
Multi-center Dynamic Investigation and Research on Nutritional Status of Inpatients
An observational study of Nutrition, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
we use the tools of SGA and NRS2002 to understand the nutritional status of Chinese Han inpatients during hospitalization and discharge, and to dynamically analyze the changes in the process of internal medicine and surgery in many general hospitals across Zhejiang Province. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- What is being tested?
- Apply SGA and NRS2002
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2014to 31 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inpatients in the hospital
Who may be able to join
- Newly hospitalized patients ≥ 18 years old;
- The length of hospital stay is 7-30 days;
- Those who have not undergone surgery before 8 o'clock the next day;
- Consciousness;
- Willing to accept the assessment and sign the informed consent form.
Who cannot join
- Age <18 years old;
- The hospital stay is less than 7 days or more than 30 days;
- Those undergoing surgery before 8 o'clock the next day;
- Unconsciousness;
- Inpatients who refuse to be assessed.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hanzhong, Zhejiang, 310009
About this study
Official title: Multi-center Dynamic Investigation and Research on Nutritional Status of InpatientS
we use the tools of SGA and NRS2002 to understand the nutritional status of Chinese Han inpatients during hospitalization and discharge, and to dynamically analyze the changes in the process of internal medicine and surgery in many general hospitals across Zhejiang Province.
Read the detailed description
his study was conducted in parallel in a number of Grade-A hospitals across the country.
The researchers used SGA and NRS2002 and other data measurement tools to collect patient information.
- General survey: initials, age, height, weight, gender, birthday, nationality;
- Admission and discharge diagnosis: primary diagnosis and secondary diagnosis;
- Laboratory indicators at admission and discharge: white blood cell, lymphocyte count, hemoglobin, platelet; Liver function (ALT and TBIL); kidney function (BUN and CR); protein (total protein, albumin and Prealbumin); blood lipids (cholesterol and triglycerides), etc.: The above results are subject to laboratory examinations within 3 days of hospitalization and discharge, and collect as complete as possible;
- Anthropometric indicators at admission and discharge: hand grip, calf circumference or upper arm circumference, etc.
- Comprehensive evaluation tools at admission and discharge: subjective comprehensive nutritional assessment (SGA) and nutritional risk screening (NRS2002);
- Description of nutritional support during hospitalization: no nutritional support, pure enteral nutrition support, pure parenteral nutrition support, enteral + parenteral nutrition support;
- Clinical outcome indicators at discharge: 30-day hospitalization mortality, total complications, infection complications, length of stay, total medical expenses, etc.
- Conditions
- Nutrition
- Being tested
- Apply SGA and NRS2002
- Keywords
- SGA NRS2002 nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apply SGA and NRS2002Other
Special researchers appointed by the research unit apply SGA and NRS2002 and other data measurement tools to collect patient information
| Study group | Role | What they receive |
|---|---|---|
| General Surgery | This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. Receives: Other: Apply SGA and NRS2002 | |
| Thoracic Surgery | This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. Receives: Other: Apply SGA and NRS2002 | |
| orthopedics | This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. Receives: Other: Apply SGA and NRS2002 | |
| Gastroenterology | This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. Receives: Other: Apply SGA and NRS2002 | |
| Respiratory | This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. Receives: Other: Apply SGA and NRS2002 | |
| Neurology | This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. Receives: Other: Apply SGA and NRS2002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the nutritional status of Chinese Han inpatients during hospitalization and discharge
Use NRS 2002 to understand the nutritional status of Chinese Han inpatients during hospitalization and discharge, and dynamically analyze the change process.
Measured: 2014-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start20 Apr 2014
- Primary completion30 Oct 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Central Hospital, Huizhou Municipal Central Hospital
- Responsible party
- Sponsor
- Investigators
- Fang He, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974112
- Sponsor's protocol ID
- 2014-138
- Status last verified
- May 2015
- First submitted
- 13 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Dynamic Investigation and Research on Nutritional Status of InpatientS
- ClinicalTrials.gov ID
- NCT04974112
- Acronym / sponsor ID
- 2014-138
- Conditions
- Nutrition
- Keywords
- SGA NRS2002 nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jinhua Central Hospital, Huizhou Municipal Central Hospital
- Study start
- 20 Apr 2014 (actual)
- Primary completion
- 30 Oct 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
we use the tools of SGA and NRS2002 to understand the nutritional status of Chinese Han inpatients during hospitalization and discharge, and to dynamically analyze the changes in the process of internal medicine and surgery in many general hospitals across Zhejiang Province.
Detailed description
his study was conducted in parallel in a number of Grade-A hospitals across the country.
The researchers used SGA and NRS2002 and other data measurement tools to collect patient information.
- General survey: initials, age, height, weight, gender, birthday, nationality;
- Admission and discharge diagnosis: primary diagnosis and secondary diagnosis;
- Laboratory indicators at admission and discharge: white blood cell, lymphocyte count, hemoglobin, platelet; Liver function (ALT and TBIL); kidney function (BUN and CR); protein (total protein, albumin and Prealbumin); blood lipids (cholesterol and triglycerides), etc.: The above results are subject to laboratory examinations within 3 days of hospitalization and discharge, and collect as complete as possible;
- Anthropometric indicators at admission and discharge: hand grip, calf circumference or upper arm circumference, etc.
- Comprehensive evaluation tools at admission and discharge: subjective comprehensive nutritional assessment (SGA) and nutritional risk screening (NRS2002);
- Description of nutritional support during hospitalization: no nutritional support, pure enteral nutrition support, pure parenteral nutrition support, enteral + parenteral nutrition support;
- Clinical outcome indicators at discharge: 30-day hospitalization mortality, total complications, infection complications, length of stay, total medical expenses, etc.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| General Surgery | – | Other: Apply SGA and NRS2002This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. |
| Thoracic Surgery | – | Other: Apply SGA and NRS2002This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. |
| orthopedics | – | Other: Apply SGA and NRS2002This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. |
| Gastroenterology | – | Other: Apply SGA and NRS2002This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. |
| Respiratory | – | Other: Apply SGA and NRS2002This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. |
| Neurology | – | Other: Apply SGA and NRS2002This study was conducted in parallel in many Class-A hospitals across the country. Special researchers were assigned by the research unit to collect patient information using SGA and NRS2002 and other data measurement tools. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients in the hospital
Key inclusion criteria (5 listed)
- Newly hospitalized patients ≥ 18 years old;
- The length of hospital stay is 7-30 days;
- Those who have not undergone surgery before 8 o'clock the next day;
- Consciousness;
- Willing to accept the assessment and sign the informed consent form.
Key exclusion criteria (5 listed)
- Age <18 years old;
- The hospital stay is less than 7 days or more than 30 days;
- Those undergoing surgery before 8 o'clock the next day;
- Unconsciousness;
- Inpatients who refuse to be assessed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apply SGA and NRS2002Special researchers appointed by the research unit apply SGA and NRS2002 and other data measurement tools to collect patient information | Other | Gastroenterology, General Surgery, Neurology, Respiratory, Thoracic Surgery, orthopedics |
Primary outcome
the nutritional status of Chinese Han inpatients during hospitalization and discharge
Time frame: 2014-10
Use NRS 2002 to understand the nutritional status of Chinese Han inpatients during hospitalization and discharge, and dynamically analyze the change process.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang He, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the nutritional status of Chinese Han inpatients during hospitalization and discharge (time frame: 2014-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.