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Clinical Trials/NCT04751032
NCT04751032
Completed
Not Applicable

Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients

Chinese Medical Association1 site in 1 country2,000 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Chinese Medical Association
Enrollment
2000
Locations
1
Primary Endpoint
Rate of mortality
Status
Completed
Last Updated
12 months ago

Overview

Brief Summary

This study is a multi-center observational study, led by the Department of Geriatrics, Peking Union Medical College Hospital, with 99 tertiary hospitals as sub-centers. Patients in the geriatrics department from September 2020 to September 2021 are consecutively enrolled .Basic information and nutritional risk assessment is registered and the outcome within 90 days after hospitalization will be recorded.Daily energy, protein and fiber are 75% of the target amount as the standard for feeding.

Detailed Description

This study is a multi-center observational study.Patients in the geriatrics department from September 2020 to September 2021 are consecutively enrolled .The patients' basic information, nutritional assessment, diet and blood biochemical indicators after hospitalization will be registered.The status of nutritional treatment and rehabilitation training and whether there is any adverse outcome when discharged from the hospital will be recorded. Daily energy, protein and fiber are 75% of the target amount as the standard for feeding.The diet, exercise status and adverse outcomes of participants within 90 days after hospitalization will be followed up through outpatient, telephone or remote consultation.Primary endpoint-the impact of nutritional therapy (energy, protein, dietary fiber compliance or failure) on mortality, new infections, falls and readmissions in elderly hospitalized patients within 90 days after hospitalization; secondary endpoints-the change of the nutrition indicators, the physical function and quality of life of the participants within 90 days after hospitalization.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 31, 2021
Last Updated
12 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients aged ≥65 years old in geriatrics;
  • Expected hospitalization ≥4 days;
  • Patients with NRS 2002≥3 points;
  • Sign informed notice.

Exclusion Criteria

  • End-stage patients (estimated survival time ≤ 3 months);
  • Transfer to other departments during hospitalization;
  • Contraindications to nutritional therapy (such as hemodynamic instability);
  • Have participated in other nutritional research projects.

Outcomes

Primary Outcomes

Rate of mortality

Time Frame: within 90 days after hospitalization

all cause mortality

Number of Participants with respiratory, urinary or gastrointestinal infections diagnosed by clinicians

Time Frame: within 90 days after hospitalization

Any infection diagnosed by a formal medical institution.Infections that require a doctor's prescription of antibiotics indicated in the medical records or diagnosis reports provided by the participants, including the respiratory tract, urinary tract, gastrointestinal tract, etc.The report or diagnosis certificate has relevant evidence, for example, the test indicates that the white blood cell is increased or the high-sensitivity C-reactive protein is increased.

Number of Participants with unplanned hospitalization for acute illness

Time Frame: within 90 days after hospitalization

Visits reported by participants because of an acute illness rather than regular visits.Hospital stays longer than 48 hours will be counted, but outpatient visits will not be counted.

Number of Participants with fall

Time Frame: within 90 days after hospitalization

Any falls reported by the participants within 90 days will be recorded. The cause of the fall and whether it is accompanied by a fracture shall be recorded.

Secondary Outcomes

  • Number of Participants with the albumin changes(Within 90 days after hospitalization)
  • Number of Participants with the physical function changes assessed by katz activity of the daily living(ADL)(Within 90 days after hospitalization)
  • Number of Participants with the quality of the life changes according to the EuroQol Five Dimensions Questionnaire(EQ-5D)(Within 90 days after hospitalization)

Study Sites (1)

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