Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients
2020年7月30日 更新者：Fresenius Kabi
Observational Cohort Study to Characterise the Current Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients Hospitalised in Intensive Care Units in Europe
The aim of this study is to characterise the use of clinical nutrition support, especially of parenteral nutrition that is administered directly into a vein, in adult patients with critical illness. The study wants to assess nutritional balance (that means the ratio of calories and protein prescribed to calories and protein actually received). Furthermore, it wants to evaluate whether the nutrition received has influence on the patients' clinical outcome, with focus on measures of physical function, such as capability of conducting daily living activities. As the study is "observational", no specific medications or treatments will be provided as part of the study to the patients.
Study patients will be observed during their stay on an intensive care unit, for a maximum duration of 15 days. Furthermore, questions on the well-being of the patients will be asked via telephone interviews 30 and 90 days after their admission to the intensive care unit.
Data of approximately 1250 patients will be collected and evaluated in this study, from approximately 100 hospitals in 11 European countries (Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, Sweden and United Kingdom).
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
1208
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Budapest、匈牙利、1096
- Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology
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Budapest、匈牙利、1134
- MH EK Honvédkorház
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Debrecen、匈牙利、4032
- University of Debrecen - Department of Anaesthesiology and Intensive Therapy
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Nyíregyháza、匈牙利、4400
- Jósa András Oktatókórház
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Székesfehérvár、匈牙利、8000
- Fejér Megyei Szent György Egyetemi Oktató Kórház
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Veszprém、匈牙利、8200
- Csolnoky Ferenc Korhaz
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Vienna、奥地利、1090
- Medical University of Vienna
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Berlin、德国、12203
- Charité Universitätsmedizin - Campus Benjamin Franklin
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Berlin、德国、13353
- Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin
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Bochum、德国、44791
- Augusta Kliniken Bochum Hattingen
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Hannover、德国、30459
- KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie
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Kiel、德国、24105
- UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel
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Leipzig、德国、04129
- Klinikum St. Georg
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Munich、德国、81377
- Klinikum der Universität München
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Stuttgart、德国、70376
- Robert-Bosch-Krankenhaus
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Wetzlar、德国、35578
- Klinikum Wetzlar-Braunfels - Klinik für Geriatrie
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Foggia、意大利、71121
- Ospedali riuniti di Foggia
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Milano、意大利、20142
- Ospedale San Paolo
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Nocera Inferiore、意大利、84014
- Ospedale Umberto I
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Ravenna、意大利、48121
- Hospital Santa Maria delle Croci
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Rimini、意大利、47900
- Ospedale Infermi Rimini
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Brno、捷克语、62500
- Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno
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Brno、捷克语、62500
- Clinic of Internal Medicine and Gastroenterology, University Hospital Brno
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Brno、捷克语、65691
- St Anne's University Hospital Brno
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Hradec Králové、捷克语、50005
- 3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Králové
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Hradec Králové、捷克语、50005
- Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové
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Hradec Králové、捷克语、50005
- III Internal Gerontometabolic Clinic, University Hospital Hradec Králové
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Olomouc、捷克语、77900
- University Hospital Olomouc Palacky University in Olomouc Faculty of Medicine and Dentistry
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Pardubice、捷克语、53003
- Hospital Pardubice Region, Inc.
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Plzen、捷克语、30460
- Charles University Hospital Plzeň
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Plzen、捷克语、30460
- University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzeň: Úvodní strana)
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Prague、捷克语、15006
- Motol University Hospital
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Prague、捷克语、12808
- General University Hospital Prague
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Ústí Nad Labem、捷克语、40011
- Masaryk Hospital
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Arlon、比利时、6700
- Vivalia - Clinique Saint Joseph
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Brussels、比利时、1090
- Universitair Ziekenhuis Brussel
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Brussels、比利时、1070
- Hospital Erasme
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Brussels、比利时、1200
- Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL)
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Charleroi、比利时、6000
- Grand Hôpital de Charleroi
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Edegem、比利时、2650
- University Hospital Antwerp
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Gent、比利时、9000
- Ghent University Hospital
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Ottignies、比利时、1340
- Saint-Pierre Clinic
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Tournai、比利时、7500
- Hospital Center of Wallonie Picarde
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Angers、法国、49100
- Centre hospitalier universitaire d'Angers
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Besançon、法国、25000
- Centre Hospitalier Régional Universitaire de Besançon
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Brest、法国、29200
- Hôpital de la Cavale Blanche à Brest
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Caen、法国、14000
- Hospital Center University Of Caen Normandie
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Chambray-lès-Tours、法国、37170
- Hôpital Trousseau - Surgical Intensive Care Unit
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Clermont-Ferrand、法国、63000
- Centre Hospitalier Universitaire de Clermont-Ferrand
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La Tronche、法国、38700
- Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon
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Lyon、法国、69003
- Hospices civils de Lyon - Hôpital Edouard Herriot
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Marseille、法国、13009
- Institut Paoli-Calmettes
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Saint-Étienne、法国、42000
- Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
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Suresnes、法国、92150
- Hôpital Foch
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Valenciennes、法国、59300
- Centre Hospitalier de Valenciennes
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Vandœuvre-lès-Nancy、法国、54500
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
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Białystok、波兰、15-276
- Uniwersytecki Szpital Kliniczny w Białymstoku
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Bydgoszcz、波兰、85-001
- 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy
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Katowice、波兰、40-055
- Medical University of Silesia
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Kraków、波兰、31-826
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.
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Opole、波兰、45-401
- Uniwersytecki Szpital Kliniczny w Opolu
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Poznań、波兰、60-479
- Szpital Wojewódzki w Poznaniu
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Stockholm、瑞典、14186
- Karolinska University Hospital, PMI Huddinge, B31
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Liverpool、英国、L7 8XP
- The Royal Liverpool University Hospital
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Liverpool、英国、L14 3PE
- Liverpool Heart and Chest Hospital
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London、英国、E1 1BB
- The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London
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Barcelona、西班牙、08907
- Hospital Universitari de Bellvitge
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Burgos、西班牙、09006
- Hospital Universitario de Burgos
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Girona、西班牙、17007
- Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit
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Lleida、西班牙、25198
- Hospital Universitari Arnau de Vilanova
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Madrid、西班牙、28031
- Hospital Universitario Infanta Leonor
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Madrid、西班牙、28942
- Hospital Universitario de Fuenlabrada - Intensive Care Unit
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Palma de Mallorca、西班牙、07120
- Hospital Universitari Son Espases
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Valencia、西班牙、46010
- Hospital Clínic de Valencia
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Valladolid、西班牙、47012
- Hospital Universitario Río Hortega
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Vigo、西班牙、36312
- Hospital Alvaro Cunqueiro
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 95年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
The study population will include adult male and female patients with critical illness (i.e.
patients requiring pharmacological and/or technical support to treat a vital threat) who are hospitalised in a medical, surgical, or trauma ICU for at least 5 consecutive calendar days.
描述
Inclusion Criteria:
- Age ≥18 years and ≤95 years, male or female
- Hospitalised in a medical, surgical, or trauma ICU for at least five consecutive calendar days and either admitted to the ICU during the predefined screening month or admitted to the ICU maximally 4 days before start of the screening month
- BMI ≥18.5 kg/m2 and ≤45 kg/m2
- Written informed consent or requirements of local/national ethical committee
Exclusion Criteria:
- Burn injury
- Pre-existing neuromuscular or psychiatric disorders that preclude proper assessment of functional status
- Severe hypoxic brain injury or severe neurological diagnosis (e.g. meningitis, encephalitis, brain trauma, spinal cord injury) at the time of ICU admission that precludes proper assessment of functional status
- Receiving home parenteral nutrition at the time of ICU admission (e.g. due to short bowel syndrome)
- Receiving home enteral nutrition (tube feeding) at the time of ICU admission
- Chronic invasive or chronic non-invasive ventilatory support before ICU admission
- Patients with a legal representative in place before ICU admission
- Admission to the ICU for palliative care
- Previous participation in this study (if the screening month is repeated and a patient is re-admitted to the ICU during the repeated screening month, only ICU data collected for that patient during the original screening month will be included)
- Concurrent enrolment in a nutrition-related interventional study at the time of screening
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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adult critically ill patients
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Proportion of patients receiving enteral nutrition (EN), parenteral nutrition (PN), and oral nutrition (ON)/oral nutrition supplements (ONS)
大体时间：from admission to ICU until discharge from ICU or death (maximum of 15 days)
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from admission to ICU until discharge from ICU or death (maximum of 15 days)
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Cumulative caloric balance
大体时间：from admission to ICU until discharge from ICU or death (maximum of 15 days)
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from admission to ICU until discharge from ICU or death (maximum of 15 days)
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Cumulative protein balance
大体时间：from admission to ICU until discharge from ICU or death (maximum of 15 days)
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from admission to ICU until discharge from ICU or death (maximum of 15 days)
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Cumulative calories (kcal/kg and total kcal) administered via EN, PN, ON/ONS, and concomitant medications (e.g. propofol, glucose, citrate, clevidipine), and via all sources combined
大体时间：from admission to ICU until discharge from ICU or death (maximum of 15 days)
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from admission to ICU until discharge from ICU or death (maximum of 15 days)
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Cumulative protein (g/kg and total g) administered via EN, PN, ON/ONS, and via all sources combined
大体时间：from admission to ICU until discharge from ICU or death (maximum of 15 days)
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from admission to ICU until discharge from ICU or death (maximum of 15 days)
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Proportion of patients with interrupted/stopped or not started clinical nutrition
大体时间：from admission to ICU until discharge from ICU or death (maximum of 15 days)
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from admission to ICU until discharge from ICU or death (maximum of 15 days)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael Hiesmayr, Prof. MD、Medical University of Vienna
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Matejovic M, Huet O, Dams K, Elke G, Vaquerizo Alonso C, Csomos A, Krzych LJ, Tetamo R, Puthucheary Z, Rooyackers O, Tjader I, Kuechenhoff H, Hartl WH, Hiesmayr M. Medical nutrition therapy and clinical outcomes in critically ill adults: a European multinational, prospective observational cohort study (EuroPN). Crit Care. 2022 May 18;26(1):143. doi: 10.1186/s13054-022-03997-z.
- Hiesmayr M, Csomos A, Dams K, Elke G, Hartl W, Huet O, Krzych LJ, Kuechenhoff H, Matejovic M, Puthucheary ZA, Rooyackers O, Tetamo R, Tjader I, Vaquerizo C. Protocol for a prospective cohort study on the use of clinical nutrition and assessment of long-term clinical and functional outcomes in critically ill adult patients. Clin Nutr ESPEN. 2021 Jun;43:104-110. doi: 10.1016/j.clnesp.2021.01.048. Epub 2021 Feb 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年11月5日
初级完成 (实际的)
2020年5月13日
研究完成 (实际的)
2020年7月30日
研究注册日期
首次提交
2019年10月25日
首先提交符合 QC 标准的
2019年10月28日
首次发布 (实际的)
2019年10月29日
研究记录更新
最后更新发布 (实际的)
2020年7月31日
上次提交的符合 QC 标准的更新
2020年7月30日
最后验证
2020年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.