Nutrition Support on Outcomes and Cost-effectiveness for Patients at Risk
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|ClinicalTrials.gov Identifier: NCT00289380|
Recruitment Status : Recruiting
First Posted : February 9, 2006
Last Update Posted : November 28, 2017
- The aim of this large scale study to survey the prevalence of nutritional risk and malnutrition in China,Europe and USA.
- 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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|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 Start Date :||January 2005|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Nutrition support cohort means accept nutrition support，it was defined as ≥15kal/kg/d and < 30kal/kg/d of non-protein calories (carbohydrate and/or fat) and amino acids or protein≥1g/kg/d for 5~28 consecutive days.
Without nutritional support
Group received only intravenous 5 to 10% glucose and electrolyte infusions
- Infectious complication [ Time Frame: Observation will be carried from admitting end until discharge ]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
- cost effectiveness [ Time Frame: Observation will be carried from admitting end until discharge ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289380
|Contact: Zhu-Ming Jiang, M.D., FACS||+86 186 0114 firstname.lastname@example.org, email@example.com|
|Contact: Kang Yu, M.S.||+86 firstname.lastname@example.org|
|Beijing Friendship Hospital, Capital Medical University||Active, not recruiting|
|Beijing, Beijing, China, 100730|
|Peking Union Medical College Hospital||Active, not recruiting|
|Beijing, Beijing, China, 100730|
|Chongqing Medical Univ. Hospital||Completed|
|Chongqing, Chongqing, China|
|Xin Qiao Hospital||Recruiting|
|Chongqing, Chongqing, China|
|Contact: Hua Yang, M.D. +86 13668057773 email@example.com|
|Principal Investigator: Hua Yang, M.D.|
|The First Affiliated Hospital, Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Wen-hua Zhan, M.D. +86 20 87755766 firstname.lastname@example.org|
|Principal Investigator: Wen-hua Zhan, M.D.|
|Sub-Investigator: Xiao-qing Liu, M.D.|
|The First Affiliated Hospial, Guangxi Medical University||Recruiting|
|Nanning, Guangxi, China, 530021|
|Contact: Ning Xia, M.D. +86 771 5303201|
|Principal Investigator: Ning Xia, M.D.|
|The First University Hospital, Hebei Medical University||Recruiting|
|Shijiazhuang, Hebei, China, 050031|
|Contact: Ru-mei Jia, M.D. +86 311 85917000 email@example.com|
|Principal Investigator: Ru-mei Jia, M.D.|
|Nankai Hospital||Active, not recruiting|
|Tianjin, Hebei, China, 300100|
|Tongji Hospital, Huazhong University of Science and Technology||Recruiting|
|Wuhan, Hubei, China, 430030|
|Contact: Yi-ping Wu, M.D. +86 27 62363420 firstname.lastname@example.org|
|Principal Investigator: Yi-ping Wu, M.D.|
|Nanjing General Hospital of Nanjing Military Command||Recruiting|
|Nanjing, Jiangsu, China, 210002|
|Contact: Zhi-wei Jiang, M.D. +86 25 84619727 email@example.com|
|Principal Investigator: Zhi-wei Jiang, M.D.|
|Xin Hua Hospital, Shanghai Jiaotong University||Recruiting|
|Shanghai, Shanghai, China, 200029|
|Contact: Wei Cai, M.D. +86 21 65790000 firstname.lastname@example.org|
|Principal Investigator: Wei Cai, M.D.|
|Shanghai, Shanghai, China|
|Contact: Huai-Long Qin, M.D. email@example.com|
|Sub-Investigator: Huai-Long Qin, M.D.|
|The First Affiliated Hospital, Xinjiang Medical University||Active, not recruiting|
|Urumqi, Xinjiang, China, 830054|
|Second Affiliated Hospital, Zhejiang University||Active, not recruiting|
|Hangzhou, Zhejiang, China, 310006|
|Study Director:||Zhu-ming Jiang, M.D., FACS||Peking Union Medical College Hospital|