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Идёт набор NCT07501195

Methods for Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients

— Наблюдательное Malnutrition Elderly Kidney Diseases Dehydration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Malnutrition Elderly, Kidney Diseases, Dehydration. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

Methods for Assessing Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients - An Observational Study (MIKADO)

Обзор

The goal of this observational study, is to improve the diagnostic assessment method of malnutrition and kidney diseases, amongst hospitalized and low priority patients, by evaluating modern methodology and biomarkers, with regards to an estimate of the nutritional status and kidney diseases, against current gold standards, and also investigate how body composition, hydration, inflammation and age affect the assessments.

Первичные конечные точки

  • To investigate whether the method used to determine body composition affects the diagnosis of malnutrition when applying the GLIM criteria. [Срок оценки: Time of inclusion and/or 14 days after preliminary inclusion.]
  • To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in acutely hospitalized patients with a cystatin C/kreatinin ratio <0,7 (patients from groups 1 and 2) [Срок оценки: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)]
  • To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in patients aged ≥90 år (patients from groups 1 and 3) [Срок оценки: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)]
  • To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in patients with BMI ≥35 kg/m2 (patients from groups 1 and 4) [Срок оценки: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)]
  • To determine changes in mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5) [Срок оценки: From enrollment to approximately 10-35 days after prednisolone treatment]
  • To determine changes in mGFRDBS before and after amputation (patients from group 6) [Срок оценки: From enrollment to follow-up after amputation (approximately 3 weeks after operation)]
Вторичные конечные точки (12)
  • To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5) [Срок оценки: From enrollment to approximately 10-35 days after prednisolone treatment]
  • To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS before and after amputation (patients from group 6) [Срок оценки: From enrollment to follow-up after amputation (approximately 3 weeks after operation)]
  • To investigate the impact of body composition on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Срок оценки: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
  • To investigate the impact of hydration status on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Срок оценки: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
  • To investigate the impact of inflammatory and aging markers on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Срок оценки: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
  • To investigate the impact of nutritional status on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Срок оценки: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
  • To investigate the impact of performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to dosing of renal risk medications (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Срок оценки: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
  • To investigate the prevalence of sarcopenia and sarcopenic obesity, and to characterize these groups. [Срок оценки: At inclusion and after 2 weeks]
  • To investigate whether the estimation of body composition is affected by patient dehydration [Срок оценки: 2 weeks after inclusion]
  • To investigate how differences between GFR estimates are affected by hydration [Срок оценки: At Inclusion and two weeks after]
  • To determine whether the use of medications with potential dehydrating effects can predict dehydration." [Срок оценки: Atr inclusion and two weeks after]
  • To investigate the prevalence of dehydration [Срок оценки: At inclusion and two weeks after]

Критерии участия

Критерии включения

  • 65 years or older (group 1, 4 and 5)
  • 90 years or older (group 3)
  • Acute admission (group 1, 2)
  • Cognitively able to cooperate (group 1)
  • Able to read and speak Danish (group 1, 2, 3, 4, 5, 6)
  • BMI ≥ 35 kg/m2 (group 4)
  • Prednisolon treatment for COPD (≥ 37,5 mg daily) (group 5)
  • Amputation(s) of crus or femur (non-traumatic) (group 6)

Критерии исключения

  • Isolation (group 1, 2, 3, 4, 5, 6)
  • Terminal treatment (group 1, 2, 3, 4, 5, 6)
  • Suicidal (group 1, 2, 3, 4, 5, 6)
  • Active Immune suppressing treatment (group 2, 3, 4, 5, 6)
  • Oedemas (group 2, 3, 4, 5, 6)
  • In active treatment for cancer (group 2, 3, 4, 5, 6)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 1 центр
  • Hvidovre Hospital — Copenhagen

Идентификаторы

NCT: NCT07501195 · 89194

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗