Comparison of CIPA With the GLIM Criteria and Prevalence of Sarcopenia in Inpatients

Sponsor

University Hospital of the Nuestra Señora de Candelaria (Other)

Overall Status

Recruiting

CT.gov ID

NCT06031766

Collaborator

(none)

490

Enrollment

Location

29.7

Anticipated Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine the diagnostic quality of the CIPA tool, in inpatients with stays longer than three days, in the observation of risk of malnutrition compared to the gold standard GLIM as a diagnosis of malnutrition.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition	Dietary Supplement: Dietary supplement

Detailed Description

Background: malnutrition is a poor prognostic factor in inpatients. Its early detection, together to nutritional intervention, can improve clinical evolution. It is important to carry out nutritional screening, however, there is no gold standard, and CIPA (Control of Intakes, Proteins and Anthropometry) has been implemented in our setting. The GLIM criteria (Global Leadership Initiative on Malnutrition) aim to provide a global consensus that allows common criteria for malnutrition diagnosis. The objective of this study is to evaluate the diagnostic quality of the CIPA screening vs the GLIM criteria for malnutrition as well as to establish the prevalence of sarcopenia.

Methods: cross-sectional single-center study comparing the diagnostic quality of CIPA in the diagnosis of malnutrition or risk of presenting it in inpatients vs GLIM. Adults of both sexes with a hospital stay of more than three days and attached to one of the following departments will be included: general surgery, internal medicine, vascular surgery, digestive system, hematology, nephrology, pulmonology, oncology, neurology, traumatology. The diagnostic evaluation of malnutrition and functionality will be carried out after three days of hospital stay, once the CIPA screening has been carried out. The participation of the patients in the study will consist of performing the CIPA malnutrition screening to which the GLIM test will be added. For the CIPA test, the BMI (body mass index), albumin levels and percentage of decreased intake will be taken. For the GLIM test, phenotypic criteria such as non-voluntary weight loss and reduction in muscle mass will also be studied together with etiological criteria to which, in addition to those referred to for the CIPA test, the presence of inflammation will be added. The study consists of a first cross-sectional part that will be completed once the data of the 490 subjects selected through probabilistic sampling has been collected. The second part of the study will consist of the prospective follow-up of the patients and the variables will be analyzed with prognostic criteria.

Discussion: this study will evaluate the diagnostic quality of CIPA vs the GLIM criteria for malnutrition and will establish the prevalence of sarcopenia in inpatients.

Study Design

Study Type:

Observational

Anticipated Enrollment :

490 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Comparison of CIPA With the GLIM Criteria of Malnutrition and Prevalence of Sarcopenia in Inpatients

Actual Study Start Date :

Jan 7, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

The concordance between CIPA test and the GLIM criteria determined by the Kappa coefficient. [6 months]

Secondary Outcome Measures

Incidence of mortality [6 months]
Mean length of stay (days) [6 months]
Incidence of readmissions [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult subjects (> 18 years old).
Hospital stay more than 3 days.
Admitted to one of the following departments: general surgery, internal medicine, vascular surgery, digestive system, hematology, nephrology, pulmonology, oncology, neurology, traumatology.

Exclusion Criteria:

Subjects with a prognosis of hospital stay less or equal than 3 days.
Admitted to services with a low incidence of malnutrition: ophthalmology, dermatology or obstetrics.
Admitted or critical care unit and palliative care.
Pediatric patient.
Patients treated with nutritional support before CIPA screening is performed.
Patients with edema-ascitic overload.