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

NCT ID: NCT05917418

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-12-01
• Study Completion Date: 2040-01-30

Brief Summary

The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.

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).

Investigators 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.

Investigators 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, the 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.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Nutritional support therapy group

All participants in this group will receive proper nutritional support.

Group Type: EXPERIMENTAL

nutritional support

Intervention Type: DIETARY_SUPPLEMENT

nutritional support

Routine hospital management group

All participants in this group will receive routine hospital management, without additional nutritional interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

nutritional support

nutritional support

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Zhu-ming Jiang

Professor of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CMA2023CSPEN

Identifier Type: -

Identifier Source: org_study_id