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

Malnutrition Clinical Trial

Official title:

1. Prevalence of Nutritional Risk-undernutrition-support in China-Euro-USA. 2. Impact of Nutrition Support on Outcome for Patient at Risk. 3. Impact of Nutrition Support on Outcome,Cost/Effectiveness for Patient at Risk.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00289380
• Other study ID #: CMA2005CSPEN
• Status: Recruiting
• Start date: January 2005
• Est. completion date: January 2040

Study information

• Verified date: June 2024
• Source: Peking Union Medical College
• Contact: Zhu-Ming Jiang, M.D., FACS
• Phone: +86 186 0114 8800
• Email: jiangzm[@]imicams.ac.cn, jiangzhm[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. The aim of this large scale study to survey the prevalence of nutritional risk and malnutrition in China,Europe and USA.

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

Already get the approval by Ethics Committee of Peking Union medical college and Johns Hopkins Hospital.

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).

We 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.

we 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,our 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.

In plan this protocol might be completed around 2016 also.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2040
• Est. primary completion date: January 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 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
• Nutritional Risk

Locations

Country	Name	City	State
China	Beijing Chest Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Chongqing Medical Univ. Hospital	Chongqing	Chongqing
China	Xin Qiao Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Second Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Nanjing General Hospital of Nanjing Military Command	Nanjing	Jiangsu
China	The First Affiliated Hospial, Guangxi Medical University	Nanning	Guangxi
China	Sixth Hospital	Shanghai	Shanghai
China	Xin Hua Hospital, Shanghai Jiaotong University	Shanghai	Shanghai
China	The First University Hospital, Hebei Medical University	Shijiazhuang	Hebei
China	Nankai Hospital	Tianjin	Hebei
China	The First Affiliated Hospital, Xinjiang Medical University	Urumqi	Xinjiang
China	Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

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	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	Observation will be carried from admitting end until discharge
Secondary	cost effectiveness	The cost effectiveness analysis was performed from the payers' perspective.The percentage of infectious complication-free patients was used to measure the effectiveness. The total cost 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. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the costs difference between the nutrition support cohort and no-nutrition support cohort by their difference in effectiveness.	Observation will be carried from admitting end until discharge