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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00289380
Other study ID # CMA2005CSPEN
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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