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

Sponsor

Peking Union Medical College (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05917418

Collaborator

(none)

400

Enrollment

Locations

Arms

198

Anticipated Duration (Months)

200

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malnutrition	Dietary Supplement: nutritional support	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Impact of Nutritional Support on Outcome,Cost/Effectiveness for Patient at Risk

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jan 30, 2040

Anticipated Study Completion Date :

Jan 30, 2040

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nutritional support therapy group All participants in this group will receive proper nutritional support.	Dietary Supplement: nutritional support nutritional support
No Intervention: Routine hospital management group All participants in this group will receive routine hospital management, without additional nutritional interventions.

Arm

Intervention/Treatment

Experimental: Nutritional support therapy group

All participants in this group will receive proper nutritional support.

Dietary Supplement: nutritional support

nutritional support

No Intervention: Routine hospital management group

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

Outcome Measures

Primary Outcome Measures

The incidence of Infectious complication [during the hospital stay]
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 Outcome Measures

Total cost amount [during the hospital stay]
The total cost amount 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
2	Beijing Chest Hospital, Capital Medical University	Beijing	Beijing	China	101149

Sponsors and Collaborators

Peking Union Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhu-ming Jiang, Professor of General Surgery, Peking Union Medical College

ClinicalTrials.gov Identifier:

NCT05917418

Other Study ID Numbers:

CMA2023CSPEN

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Jun 23, 2023