Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk
Primary Purpose
Malnutrition
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nutritional support
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition
Eligibility Criteria
Inclusion Criteria: patients be in hospital overnight diagnoses according to the protocol of cohort study for cost effectiveness Exclusion Criteria: patients admitting from emergency department patients who undergone operation before second morning of hospitalization patients who dose not give Informed Consents
Sites / Locations
- Peking Union Medical College Hospital
- Beijing Chest Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional support therapy group
Routine hospital management group
Arm Description
All participants in this group will receive proper nutritional support.
All participants in this group will receive routine hospital management, without additional nutritional interventions.
Outcomes
Primary Outcome Measures
The incidence of Infectious complication
A infectious complication was defined as as the presence of recognized pathogens in body tissues that normally are sterile, confirmed by the results of culture and supported by clinical, radiologic or hematologic evidence of infection
Secondary Outcome Measures
Total cost amount
The total cost amount was considered to contain 3 items in our study. The first item was the cost of nutrition support, including nutrition solutions, nursing, physician, and other staff supervision of nutrition support preparation, administration, and catheter placement and maintenance. The second item was the cost of the infectious complication.The third item was 'other costs' associated with the hospital admission, calculated from the total costs from which the cost of nutrition support and infectious complications were subtracted.
Full Information
NCT ID
NCT05917418
First Posted
June 3, 2023
Last Updated
June 15, 2023
Sponsor
Peking Union Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05917418
Brief Title
Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk
Official Title
Impact of Nutritional Support on Outcome,Cost/Effectiveness for Patient at Risk
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
January 30, 2040 (Anticipated)
Study Completion Date
January 30, 2040 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.
Detailed Description
Although it was often to hear that malnutrition ratio in Aisa hospitalized patient was 40%-70% , there was no evidence to elaborate the prevalence of nutritional risk and malnutrition on hospitalized patients of Asia. Also in USA no data for nutritional risk. In 2002, scientists group headed by Kondrup from : European Society for Parenteral and Enteral Nutrition demonstrated that randomized controlled clinical trials showed patients may get benefit from nutrition support when they with nutrition risk. Based on these evidences, a simpler method was established by European Society for Parenteral and Enteral Nutrition in year 2002 in Munich & it was demonstrated useful to evaluate the appropriate use of nutrition support at present time. This method was named as Nutrition Risk Screening (NRS).
Investigators propose to survey the prevalence of malnutrition & nutrition risk in large cities' large/middle size hospitalized patients in China, Europe and USA use NRS tool. As well, we also aim to figure out the current nutrition support status in current large/middle size hospitals through this survey.
Investigators also propose to evaluate the cost-effectiveness of parenteral nutrition, enteral nutrition and non-nutritional support, and to examine the clinical outcomes of nutritional support in certain patients at nutritional risk identified by NRS-2002.
For international cooperation, the partners are Professor Kondrup of Europe and Professor Nolan from Johns Hopkins Hospital,there are students from a cooperative project with Johns Hopkins Hospital for Doctor of Philosophy students 2005-2011.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutritional support therapy group
Arm Type
Experimental
Arm Description
All participants in this group will receive proper nutritional support.
Arm Title
Routine hospital management group
Arm Type
No Intervention
Arm Description
All participants in this group will receive routine hospital management, without additional nutritional interventions.
Intervention Type
Dietary Supplement
Intervention Name(s)
nutritional support
Intervention Description
nutritional support
Primary Outcome Measure Information:
Title
The incidence of Infectious complication
Description
A infectious complication was defined as as the presence of recognized pathogens in body tissues that normally are sterile, confirmed by the results of culture and supported by clinical, radiologic or hematologic evidence of infection
Time Frame
during the hospital stay
Secondary Outcome Measure Information:
Title
Total cost amount
Description
The total cost amount was considered to contain 3 items in our study. The first item was the cost of nutrition support, including nutrition solutions, nursing, physician, and other staff supervision of nutrition support preparation, administration, and catheter placement and maintenance. The second item was the cost of the infectious complication.The third item was 'other costs' associated with the hospital admission, calculated from the total costs from which the cost of nutrition support and infectious complications were subtracted.
Time Frame
during the hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients be in hospital overnight
diagnoses according to the protocol of cohort study for cost effectiveness
Exclusion Criteria:
patients admitting from emergency department
patients who undergone operation before second morning of hospitalization
patients who dose not give Informed Consents
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Chest Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
12. IPD Sharing Statement
Learn more about this trial
Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk
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