Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk

Malnutrition Clinical Trial

Official title:

Impact of Nutritional Support on Outcome,Cost/Effectiveness for Patient at Risk

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05917418
• Other study ID #: CMA2023CSPEN
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: January 30, 2040

Study information

• Verified date: June 2024
• Source: Peking Union Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 30, 2040
• Est. primary completion date: January 30, 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• nutritional support
nutritional support

Locations

Country	Name	City	State
China	Beijing Chest Hospital, Capital Medical University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during the hospital stay
Secondary	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.	during the hospital stay