Nutrition Support on Outcomes and Cost-effectiveness for Patients at Risk
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| ClinicalTrials.gov Identifier: NCT00289380 |
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Recruitment Status :
Recruiting
First Posted : February 9, 2006
Last Update Posted : March 10, 2020
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| Tracking Information | |||||||||
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| First Submitted Date | February 8, 2006 | ||||||||
| First Posted Date | February 9, 2006 | ||||||||
| Last Update Posted Date | March 10, 2020 | ||||||||
| Study Start Date | January 2005 | ||||||||
| Estimated Primary Completion Date | January 2040 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Not Provided | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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.
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| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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. | ||||||||
| Brief Summary |
Already get the approval by Ethics Committee of Peking Union medical college and Johns Hopkins Hospital. |
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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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
2000 | ||||||||
| Original Enrollment |
12000 | ||||||||
| Estimated Study Completion Date | January 2040 | ||||||||
| Estimated Primary Completion Date | January 2040 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT00289380 | ||||||||
| Other Study ID Numbers | CMA2005CSPEN | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Zhu-ming Jiang, Peking Union Medical College | ||||||||
| Study Sponsor | Peking Union Medical College | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Peking Union Medical College | ||||||||
| Verification Date | March 2020 | ||||||||