Clinical trial NCT00289380: Nutrition Support on Outcomes and Cost-effectiveness for Patients at Risk
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Nutritional Risk
Keywords: Nutritional Risk Screening(NRS)
Malnutrition
Overweight
Obesity
Clinical nutritional support
Clinical outcome
Cost effectiveness
Complication
Infective complications
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2006-02-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Continuing sampling in 6 clinical Departments of large, middle \& small size hospitals in 15 large cities from West, Middle \& East China.

Also, data from Denmark and USA will be collected and analysed.

Brief 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.

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).

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.

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

Primary outcomes:
measure: Infectious complication
timeFrame: Observation will be carried from admitting end until discharge
Secondary outcomes:
measure: cost effectiveness
timeFrame: Observation will be carried from admitting end until discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing Medical Univ. Hospital
state: Chongqing
city: Chongqing
country: China
facility: Xin Qiao Hospital
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospial, Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The First University Hospital, Hebei Medical University
state: Hebei
city: Tianjin
country: China
facility: Nankai Hospital
state: Hebei
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Command
state: Jiangsu
city: Shanghai
country: China
facility: Xin Hua Hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Sixth Hospital
state: Shanghai
city: Urumqi
country: China
facility: The First Affiliated Hospital, Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhu-ming Jiang, M.D., FACS
role: STUDY_DIRECTOR
References:
citation: Jie B, Jiang ZM, Nolan MT, Efron DT, Zhu SN, Yu K, Kondrup J. Impact of nutritional support on clinical outcome in patients at nutritional risk: a multicenter, prospective cohort study in Baltimore and Beijing teaching hospitals. Nutrition. 2010 Nov-Dec;26(11-12):1088-93. doi: 10.1016/j.nut.2009.08.027. Epub 2009 Dec 5.