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临床试验/NCT06031766
NCT06031766招募中不适用

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

University Hospital of the Nuestra Señora de Candelaria1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2022年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
490
试验地点
1
主要终点
The concordance between CIPA test and the GLIM criteria determined by the Kappa coefficient.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 6 months

次要结局

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

研究者

发起方
University Hospital of the Nuestra Señora de Candelaria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Marquez Mesa

Assistant doctor in Endocrinology and Nutrition

University Hospital of the Nuestra Señora de Candelaria

研究点 (1)

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