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

Peking Union Medical College

Status: Enrolling

Conditions: Malnutrition; Nutritional Risk

Study type: Observational

Funder types: Other

Identifiers

NCT00289380

CMA2005CSPEN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Nutrition support

Description:

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

Description:

Group received only intravenous 5 to 10% glucose and electrolyte infusions