NCT06062914

Brief Summary

The goal of this observational study is to evaluate the treatment effect and health economic impact of oral nutritional supplements(ONS) in hospitalized patients with nutritional risk. The main questions it aims to answer are:

  • To evaluate the effect of ONS on clinical outcomes in hospitalized patients with high nutritional risk
  • To evaluate the health economic impact of ONS in hospitalized patients with high nutritional risk Data was collected from patients admitted to peking union medical college hospital between January 1, 2018 and December 31, 2020. The inclusion criteria were as follows: (1) age≥18 years old; (2)length of hospital stay≥3days; (3) Only ONS was used as enteral nutrition or no enteral nutrition was received. Exclusion criteria were: (1) age\<18; (2) length of hospital stay\<3 days; (3) the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions; (5) the patients who transferred from other hospitals; (6) pregnancy or lactation We collected the following data through the hospital big data query and analysis system:
  • Basic information: gender, age, height, weight, medical insurance, etc.
  • Clinical information: admission paths, admission time, admission departments, discharge time, discharge unit, length of stay, mode of payment；
  • Disease Information: admission diagnosis, disease coding at admission, the first discharge diagnosis, the coding of first discharge diagnosis, the second discharge diagnosis, the third discharge diagnosis, outcome (recovery, improvement, not cured, death, transfer to another hospital)
  • Operation information: surgical name, surgery code,
  • oral nutritional supplement: drug names, unit price
  • laboratory examination: hemoglobin, albumin, prealbumin
  • hospitalization costs: total cost, self-pay cost, other cost, the type of medical insurance； Researchers will compare ONS group to see the clinical outcomes and health economic impact.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 7, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

October 10, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

September 18, 2023

Last Update Submit

October 9, 2023

Conditions

MalnutritionNutritional Risk

Outcome Measures

Primary Outcomes (1)

  • total cost

    The total cost of hospitalization for the patient

    through study completion, an average of 1 month

Secondary Outcomes (1)

  • mortality

    through study completion, an average of 1 month

Study Arms (2)

oral nutritional supplement group

Only oral nutritional supplement was used as enteral nutrition, including but not limited to Ensure®, Nutrison® and etc.

Drug: oral nutritional supplements

no-oral nutritional supplement group

no enteral nutrition was received

Interventions

oral nutritional supplementsDRUG

Only ONS was used as enteral nutrition

oral nutritional supplement group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitalized patients with nutritional risk

You may qualify if:

  • age≥18 years old;
  • length of hospital stay ≥3days;
  • Only ONS was used as enteral nutrition or no enteral nutrition was received.

You may not qualify if:

  • age\<18;
  • length of hospital stay\<3 days;
  • the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions;
  • (5) the patients who transferred from other hospitals; (6) pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Yu Wang

CONTACT

+86 18382008790med_wangyu@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

October 2, 2023

Study Start

October 7, 2023

Primary Completion

November 7, 2023

Study Completion

November 30, 2023

Last Updated

October 10, 2023

Record last verified: 2023-09

Locations

CN(1)