NCT05917418

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
160mo left

Started Dec 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
3.4 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2040

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2040

Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

13.2 years

First QC Date

June 3, 2023

Last Update Submit

January 7, 2026

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • The incidence of Infectious complication

    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

    during the hospital stay

Secondary Outcomes (1)

  • Total cost amount

    during the hospital stay

Study Arms (2)

Nutritional support therapy group

EXPERIMENTAL

All participants in this group will receive proper nutritional support.

Dietary Supplement: nutritional support

Routine hospital management group

NO INTERVENTION

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

Interventions

nutritional supportDIETARY_SUPPLEMENT

nutritional support

Nutritional support therapy group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients be in hospital overnight
  • diagnoses according to the protocol of cohort study for cost effectiveness

You may not qualify if:

  • patients admitting from emergency department
  • patients who undergone operation before second morning of hospitalization
  • patients who dose not give Informed Consents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of General Surgery

Study Record Dates

First Submitted

June 3, 2023

First Posted

June 23, 2023

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

January 30, 2040

Study Completion (Estimated)

January 30, 2040

Last Updated

January 9, 2026

Record last verified: 2025-12

Locations

CN(2)