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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031766
• Other study ID #: UniversityHNSC
• Status: Recruiting
• Start date: January 7, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: University Hospital of the Nuestra Señora de Candelaria
• Contact: Elena Márquez Mesa, Physician
• Phone: 697232171
• Email: elenamqz[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Intervention

Dietary Supplement:
• Dietary supplement
The participation of the patients in the study will consist of performing the screening for malnutrition that is usually used in the hospital (CIPA) to which the GLIM test will be added, considered as the gold standard for this work. Subsequently, the sample of patients with a positive CIPA (as it is currently considered the screening test used in the hospital) will be implemented the therapeutic measures according to the usual protocol, while the subjects with a negative CIPA test but a positive GLIM will be studied. and constant monitoring taking the appropriate measures according to optional criteria. The patients will be followed up for the study of prognostic factors based on the variables obtained.

Locations

Country	Name	City	State
Spain	UniversityHNSC	Santa Cruz de Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of the Nuestra Señora de Candelaria

Country where clinical trial is conducted

Spain, 

References & Publications (18)

Alvarez-Hernandez J, Planas Vila M, Leon-Sanz M, Garcia de Lorenzo A, Celaya-Perez S, Garcia-Lorda P, Araujo K, Sarto Guerri B; PREDyCES researchers. Prevalence and costs of malnutrition in hospitalized patients; the PREDyCES Study. Nutr Hosp. 2012 Jul-Au — View Citation

Ballesteros-Pomar MD, Gajete-Martin LM, Pintor-de-la-Maza B, Gonzalez-Arnaiz E, Gonzalez-Roza L, Garcia-Perez MP, Gonzalez-Alonso V, Garcia-Gonzalez MA, de Prado-Espinosa R, Cuevas MJ, Fernandez-Perez E, Mostaza-Fernandez JL, Cano-Rodriguez I. Disease-Rel — View Citation

Bellanti F, Lo Buglio A, Quiete S, Pellegrino G, Dobrakowski M, Kasperczyk A, Kasperczyk S, Vendemiale G. Comparison of Three Nutritional Screening Tools with the New Glim Criteria for Malnutrition and Association with Sarcopenia in Hospitalized Older Pat — View Citation

Boulhosa RSSB, Lourenco RP, Cortes DM, Oliveira LPM, Lyra AC, de Jesus RP. Comparison between criteria for diagnosing malnutrition in patients with advanced chronic liver disease: GLIM group proposal versus different nutritional screening tools. J Hum Nut — View Citation

Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, — View Citation

Clark AB, Reijnierse EM, Lim WK, Maier AB. Prevalence of malnutrition comparing the GLIM criteria, ESPEN definition and MST malnutrition risk in geriatric rehabilitation patients: RESORT. Clin Nutr. 2020 Nov;39(11):3504-3511. doi: 10.1016/j.clnu.2020.03.0 — View Citation

Correia MITD, Tappenden KA, Malone A, Prado CM, Evans DC, Sauer AC, Hegazi R, Gramlich L. Utilization and validation of the Global Leadership Initiative on Malnutrition (GLIM): A scoping review. Clin Nutr. 2022 Mar;41(3):687-697. doi: 10.1016/j.clnu.2022. — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older Peopl — View Citation

Garlini LM, Alves FD, Ceretta LB, Perry IS, Souza GC, Clausell NO. Phase angle and mortality: a systematic review. Eur J Clin Nutr. 2019 Apr;73(4):495-508. doi: 10.1038/s41430-018-0159-1. Epub 2018 Apr 26. — View Citation

Gomes F, Baumgartner A, Bounoure L, Bally M, Deutz NE, Greenwald JL, Stanga Z, Mueller B, Schuetz P. Association of Nutritional Support With Clinical Outcomes Among Medical Inpatients Who Are Malnourished or at Nutritional Risk: An Updated Systematic Revi — View Citation

Lengele L, Bruyere O, Beaudart C, Reginster JY, Locquet M. Malnutrition, assessed by the Global Leadership Initiative on Malnutrition (GLIM) criteria but not by the mini nutritional assessment (MNA), predicts the incidence of sarcopenia over a 5-year in t — View Citation

Mendoza AM, Suarez Llanos JP, Delgado Brito I, Pereyra-Garcia Castro F, Lopez Travieso R, Perez Delgado N, Garcia Nunez MA, Benitez Brito N, Palacio Abizanda E. [Optimisation of nutritional screening tool CIPA: are two parameters of protein really necessa — View Citation

Mora Mendoza A, Suarez Llanos JP, Sanchez Morales A, Lorenzo Gonzalez C, Zambrano Huerta Y, Llorente Gomez de Segura I. Validation of CIPA nutritional screening through prognostic clinical variables in hospitalized surgical patients. Endocrinol Diabetes N — View Citation

Suarez Llanos JP, Benitez Brito N, Oliva Garcia JG, Pereyra-Garcia Castro F, Lopez Frias MA, Garcia Hernandez A, Diaz Sirgo B, Llorente Gomez de Segura I. [Introducing a mixed nutritional screening tool (CIPA) in a tertiary hospital]. Nutr Hosp. 2014 May — View Citation

Suarez-Llanos JP, Benitez-Brito N, Vallejo-Torres L, Delgado-Brito I, Rosat-Rodrigo A, Hernandez-Carballo C, Ramallo-Farina Y, Pereyra-Garcia-Castro F, Carlos-Romero J, Felipe-Perez N, Garcia-Niebla J, Calderon-Ledezma EM, Gonzalez-Melian TJ, Llorente-Gom — View Citation

Suarez-Llanos JP, Mora-Mendoza A, Benitez-Brito N, Perez-Mendez L, Pereyra-Garcia-Castro F, Oliva-Garcia JG, Palacio-Abizanda JE. Validity of the new nutrition screening tool Control of Food Intake, Protein, and Anthropometry (CIPA) in non-surgical inpati — View Citation

Suarez-Llanos JP, Vallejo-Torres L, Garcia-Bello MA, Hernandez-Carballo C, Calderon-Ledezma EM, Rosat-Rodrigo A, Delgado-Brito I, Pereyra-Garcia-Castro F, Benitez-Brito N, Felipe-Perez N, Ramallo-Farina Y, Romero-Perez JC. Cost-effectiveness of the hospit — View Citation

Zugasti Murillo A, Petrina-Jauregui ME, Ripa-Ciaurriz C, Sanchez Sanchez R, Villazon-Gonzalez F, Gonzalez-Diaz Faes A, Fernandez-Lopez C, Calles-Romero L, Martin Palmero MA, Riestra-Fernandez M, Dublang-Irazabal M, Rengel-Jimenez J, Diez-Muniz-Alique M, A — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concordance between CIPA test and the GLIM criteria determined by the Kappa coefficient.		6 months
Secondary	Incidence of mortality		6 months
Secondary	Mean length of stay (days)		6 months
Secondary	Incidence of readmissions		6 months