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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

Tracking Information
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
 (submitted: April 5, 2013)
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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: February 11, 2014)
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.
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
  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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.

Condition
  • Malnutrition
  • Nutritional Risk
Intervention Not Provided
Study Groups/Cohorts
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 5, 2013)
2000
Original Enrollment
 (submitted: February 8, 2006)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
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
Study Director: Zhu-ming Jiang, M.D., FACS Peking Union Medical College Hospital
PRS Account Peking Union Medical College
Verification Date March 2020