Nutrition Support on Outcomes and Cost-effectiveness for Patients at Risk
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Purpose
- 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 |
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Malnutrition |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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. |
- Infectious complication [ Time Frame: Observation will be carried from admitting end until discharge ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The cost effectiveness analysis was performed from the payers' perspective.The percentage of infectious complication-free patients was used to measure the effectiveness. The cost was defined as the sum of the cost of nutrition support and the cost of infectious complications and the indirect cost.The cost calculation was based on the statement of account which listed the price of each service, consumable, drug, examination in details, including all expenditures during hospitalization.
| Estimated Enrollment: | 2000 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Nutrition support
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.
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Without nutritional support
Without nutritional support cohort means have never receive any kind of amino acids and fat emulsion.
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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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Contact: Zhu-Ming Jiang, M.D., FACS | +86 186 0114 8800 | jiangzm@imicams.ac.cn, jiangzhuming@gmail.com |
| Contact: Kang Yu, M.S. | +86 13801130457 | yuk2004@gmail.com |
| China, Beijing | |
| 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 | |
| China, Chongqing | |
| Chongqing Medical Univ. Hospital | Completed |
| Chongqing, Chongqing, China | |
| China, Guangdong | |
| The First Affiliated Hospital, Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China, 510080 | |
| Contact: Wen-hua Zhan, M.D. +86 20 87755766 wenhuazhan@medmail.com.cn | |
| Principal Investigator: Wen-hua Zhan, M.D. | |
| Sub-Investigator: Xiao-qing Liu, M.D. | |
| China, Guangxi | |
| 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. | |
| China, Hebei | |
| The First University Hospital, Hebei Medical University | Recruiting |
| Shijiazhuang, Hebei, China, 050031 | |
| Contact: Ru-mei Jia, M.D. +86 311 85917000 jiarm@jyyy.com.cn | |
| Principal Investigator: Ru-mei Jia, M.D. | |
| Nankai Hospital | Active, not recruiting |
| Tianjin, Hebei, China, 300100 | |
| China, Hubei | |
| Tongji Hospital, Huazhong University of Science and Technology | Recruiting |
| Wuhan, Hubei, China, 430030 | |
| Contact: Yi-ping Wu, M.D. +86 27 62363420 mail@tjh.tjmu.edu.cn | |
| Principal Investigator: Yi-ping Wu, M.D. | |
| China, Jiangsu | |
| Nanjing General Hospital of Nanjing Military Command | Recruiting |
| Nanjing, Jiangsu, China, 210002 | |
| Contact: Zhi-wei Jiang, M.D. +86 25 84619727 surgery34@163.com | |
| Principal Investigator: Zhi-wei Jiang, M.D. | |
| China, Shanghai | |
| Xin Hua Hospital, Shanghai Jiaotong University | Recruiting |
| Shanghai, Shanghai, China, 200029 | |
| Contact: Wei Cai, M.D. +86 21 65790000 caiwei204@yahoo.com.cn | |
| Principal Investigator: Wei Cai, M.D. | |
| Sixth Hospital | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Huai-Long Qin, M.D. hlqin@sjtu.edu.cn | |
| Sub-Investigator: Huai-Long Qin, M.D. | |
| China, Sichuan | |
| Xin Qiao Hospital | Recruiting |
| Chong Qing, Sichuan, China | |
| Contact: Hua Yang, M.D. +86 13668057773 hyang@med.umich.edu | |
| Principal Investigator: Hua Yang, M.D. | |
| China, Xinjiang | |
| The First Affiliated Hospital, Xinjiang Medical University | Active, not recruiting |
| Urumqi, Xinjiang, China, 830054 | |
| China, Zhejiang | |
| 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 |
More Information
No publications provided by Peking Union Medical College
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Zhu-ming Jiang, Professor of General Surgery,, Peking Union Medical College |
| ClinicalTrials.gov Identifier: | NCT00289380 History of Changes |
| Other Study ID Numbers: | CMA2005CSPEN |
| Study First Received: | February 8, 2006 |
| Last Updated: | April 7, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Peking Union Medical College:
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Nutritional Risk Screening(NRS) Malnutrition Overweight Obesity Clinical nutritional support |
Clinical outcome Cost effectiveness Complication Infective complications |
Additional relevant MeSH terms:
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Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on June 17, 2013