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NCT Number: NCT00289380

Nutrition Support on Outcomes and Cost-effectiveness for Patients at Risk

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.

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Key information

Conditions

Malnutrition Body Weight Nutrition Disorders Nutritional Risk Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chest Hospital, Capital Medical University, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kang Yu, M.S.

CONTACT

[email protected]

+86 13801130457

Zhu-Ming Jiang, M.D., FACS

CONTACT

[email protected], [email protected]

+86 186 0114 8800

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Registry information

Official study 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.

Important dates

Study start: 2005
Primary completion: 2040
Study completion: 2040
First posted: Feb 9, 2006
Registry last updated: Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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