- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05276752
Short- and Long-term Health Adverse Outcomes Associated With Nutrition Disorders and Nutrition Related Conditions in Hospitalized Older People
Malnutrition is associated with health adverse outcomes such as higher risk of mobility disability, falls and, fractures and higher mortality. Malnutrition had been defined as "a state resulting from lack of intake or uptake of nutrition that leads to altered body composition (decreased fat free mass) and body cell mass leading to diminished physical and mental function and impaired clinical outcome from disease". In 2018, the European Society for Clinical Nutrition and Metabolism (ESPEN) revisited nutrition and nutrition-related conditions definitions in the ESPEN guidelines on definitions and terminology of clinical nutrition based on the findings of the last decades. Nutrition disorders and nutrition related conditions were divided in 5 categories: Malnutrition/undernutrition, sarcopenia and frailty, overweight and obesity, micronutrients abnormalities, and refeeding syndrome. The definition of malnutrition based on the Global Leadership Initiative on Malnutrition (GLIM) criteria is globally accepted by de scientific community since this was launched in 2019. The presence of at least one phenotypic (i.e., nonintentional weight loss, low body mass index or low muscle mass) and one etiologic criterion (i.e., reduced food intake or inflammation) were required to define malnutrition.
Malnutrition is a common pathological condition in older adults that can further influence and aggravate health-related muscle decline. Sarcopenia is known as a natural progressive decline in skeletal muscles occurring with age, with an age-related decline in muscle strength. According to the criteria published in 2019 by the European Working Group on Sarcopenia in Older People (EWGSOP2), this process is defined by the presence of low muscle strength and low muscle mass.
Patients in acute care are likely to present higher stay and risk of mortality. However, the mortality have rarely been applied in acute care, due to difficulties to administer Dual X-ray Absorptiometry (DXA), the gold standard method for muscle mass in acute care. Pragmatic approaches to assess nutrition and nutrition-related condition are urgently needed to provide better quality of care in clinical practice in geriatric medicine.
The primary objective of this study is to determine the impact of nutrition disorders and nutrition-related conditions at baseline (admission in hospitalization) on the all-causes mortality risk in hospitalized older people.
Secondarily, this study evaluates their impact on other health adverse outcomes: falls, fractures, rehospitalization, institutionalization, all-cause admission in intensive care, length of hospital stay, length of ventilation and USI stay.
Finally, the diagnostic performance indicators of the Mini Nutritional Assessment (MNA-SF) and the Geriatric Nutritional Risk Index (GNRI) for malnutrition assessment following the GLIM criteria were calculated.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Marie Claessens, MD
- 전화번호: 32472488182
- 이메일: marie.claessens@chu-brugmann.be
연구 장소
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Brussels, 벨기에
- 모병
- CHU Brugmann
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연락하다:
- Marie Claessens, MD
- 전화번호: 32472488182
- 이메일: marie.claessens@chu-brugmann.be
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients aged ≥60 and over admitted to the geriatric healthcare unit and/or the COVID-19 unit of the CHU Brugmann Hospital, between 01/01/2016 and 12/10/2021.
- Patients who had the assessment of nutrition disorders and/or nutrition related conditions available during their hospital admission.
Exclusion Criteria:
- No exclusion criteria based on demographical or medical data were applied.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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All-cause mortality
기간: From 2016 till 2021
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Vital status (death/alive)
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From 2016 till 2021
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Falls
기간: From 2016 till 2021
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Falls (yes/no)
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From 2016 till 2021
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Fractures of upper and lower limbs and/or hip and/or vertebrae
기간: From 2016 till 2021
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Fractures of upper and lower limbs and/or hip and/or vertebrae (yes/no)
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From 2016 till 2021
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Re-hospitalization
기간: From 2016 till 2021
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Unplanned readmission in hospital (yes/no)
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From 2016 till 2021
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Institutionalization
기간: From 2016 till 2021
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Institutionalization (yes/no)
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From 2016 till 2021
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All-cause admission in intensive care
기간: From 2016 till 2021
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All-cause admission in intensive care (yes/no)
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From 2016 till 2021
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Mechanical ventilation
기간: From 2016 till 2021
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Mechanical ventilation (yes/no)
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From 2016 till 2021
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Length of hospital stay time from admission to discharge
기간: From 2016 till 2021
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Length of hospital stay time from admission to discharge
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From 2016 till 2021
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Sensitivity
기간: From 2016 till 2021
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Diagnostic performance indicators: the ability of a screening test to identify malnourished patients according to the GLIM criteria.
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From 2016 till 2021
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Specificity
기간: From 2016 till 2021
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Diagnostic performance indicators: the ability of a screening test to identify non-malnourished patients according to the GLIM criteria.
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From 2016 till 2021
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Positive predictive value (PPV)
기간: From 2016 till 2021
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Positive predictive value is the proportion of positive screening test results that are true positives for the diagnosis of malnutrition according to GLIM criteria.
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From 2016 till 2021
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Negative predictive value (NPV)
기간: From 2016 till 2021
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Negative predictive value (NPV) is the proportion of negative screening test results that are true negative for the diagnosis of malnutrition according to the GLIM criteria.
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From 2016 till 2021
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Area under the ROC curve (AUC)
기간: From 2016 till 2021
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A measure of the precision of a quantitative diagnostic test, which gives equal weight to sensitivity and specificity.
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From 2016 till 2021
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marie Claessens, CHU Brugmann
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHUB-Nutrition disorders
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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