NCT06031766

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.

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
490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration 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

Study Start

First participant enrolled

January 7, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

August 20, 2023

Last Update Submit

September 3, 2023

Conditions

Keywords

GLIM criteriaCIPAphase anglehospital staymortalitybody compositionscreeningSarcopeniainpatientnutrition assessment

Outcome Measures

Primary Outcomes (1)

  • The concordance between CIPA test and the GLIM criteria determined by the Kappa coefficient.

    6 months

Secondary Outcomes (3)

  • Incidence of mortality

    6 months

  • Mean length of stay (days)

    6 months

  • Incidence of readmissions

    6 months

Interventions

Dietary supplementDIETARY_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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult subjects of both sexes with a hospital stay of more than three days.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversityHNSC

Santa Cruz de Tenerife, 38010, Spain

RECRUITING

Related Publications (18)

  • 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 Review and Meta-analysis. JAMA Netw Open. 2019 Nov 1;2(11):e1915138. doi: 10.1001/jamanetworkopen.2019.15138.

  • 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-Aug;27(4):1049-59. doi: 10.3305/nh.2012.27.4.5986.

  • 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, Agorreta-Ruiz JJ, Salsamendi-Perez JL, Larranaga-Unanue I, Abinzano-Guillen ML, Olariaga O, De la Cruz JJ. SeDREno study - prevalence of hospital malnutrition according to GLIM criteria, ten years after the PREDyCES study. Nutr Hosp. 2021 Oct 13;38(5):1016-1025. doi: 10.20960/nh.03638.

  • 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 Nutr (Engl Ed). 2020 May;67(5):304-309. doi: 10.1016/j.endinu.2019.07.008. Epub 2019 Oct 24. English, Spanish.

  • 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 1;29(5):1149-53. doi: 10.3305/nh.2014.29.5.7299. Spanish.

  • 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 necessary?]. Nutr Hosp. 2018 Aug 2;35(4):914-919. doi: 10.20960/nh.1701. Spanish.

  • 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 inpatients. Arch Med Sci. 2018 Aug;14(5):1020-1024. doi: 10.5114/aoms.2017.66084. Epub 2017 Feb 20.

  • 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 hospital nutrition screening tool CIPA. Arch Med Sci. 2019 Jan 11;16(2):273-281. doi: 10.5114/aoms.2018.81128. eCollection 2020.

  • 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-Gomez de Segura I, Barrera-Gomez MA. Clinical and cost-effectiveness analysis of early detection of patients at nutrition risk during their hospital stay through the new screening method CIPA: a study protocol. BMC Health Serv Res. 2017 Apr 20;17(1):292. doi: 10.1186/s12913-017-2218-z.

  • 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, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.

  • 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.2022.01.018. Epub 2022 Feb 1.

  • 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.

  • 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 People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

  • 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 Nutr Diet. 2020 Dec;33(6):862-868. doi: 10.1111/jhn.12759. Epub 2020 May 7.

  • 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.2020.03.015. Epub 2020 Mar 23.

  • 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 Patients. J Clin Med. 2020 Jun 17;9(6):1898. doi: 10.3390/jcm9061898.

  • 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-Related Malnutrition and Sarcopenia Predict Worse Outcome in Medical Inpatients: A Cohort Study. Nutrients. 2021 Aug 25;13(9):2937. doi: 10.3390/nu13092937.

  • 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 the SarcoPhAge cohort. Aging Clin Exp Res. 2021 Jun;33(6):1507-1517. doi: 10.1007/s40520-021-01880-5. Epub 2021 May 15.

MeSH Terms

Conditions

MalnutritionSarcopenia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Elena Márquez Mesa, Physician

    University HNSC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Márquez Mesa, Physician

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant doctor in Endocrinology and Nutrition

Study Record Dates

First Submitted

August 20, 2023

First Posted

September 11, 2023

Study Start

January 7, 2022

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations