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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 : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Zhu-ming Jiang, Peking Union Medical College

Study Description
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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.


Condition or disease
Malnutrition Nutritional Risk

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
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.
Study Start Date : January 2005
Estimated Primary Completion Date : January 2040
Estimated Study Completion Date : January 2040

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.
Without nutritional support
Group received only intravenous 5 to 10% glucose and electrolyte infusions


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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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
Xin Qiao Hospital Recruiting
Chongqing, Chongqing, China
Contact: Hua Yang, M.D.    +86 13668057773    hyang@med.umich.edu   
Principal Investigator: Hua Yang, M.D.         
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, 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
Sponsors and Collaborators
Peking Union Medical College
Investigators
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Study Director: Zhu-ming Jiang, M.D., FACS Peking Union Medical College Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhu-ming Jiang, Professor of General Surgery,, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT00289380    
Other Study ID Numbers: CMA2005CSPEN
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Keywords provided by Zhu-ming Jiang, Peking Union Medical College:
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