- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04143503
Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients
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).
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Berlin, 독일, 12203
- Charité Universitätsmedizin - Campus Benjamin Franklin
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Berlin, 독일, 13353
- Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin
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Bochum, 독일, 44791
- Augusta Kliniken Bochum Hattingen
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Hannover, 독일, 30459
- KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie
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Kiel, 독일, 24105
- UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel
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Leipzig, 독일, 04129
- Klinikum St. Georg
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Munich, 독일, 81377
- Klinikum der Universität München
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Stuttgart, 독일, 70376
- Robert-Bosch-Krankenhaus
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Wetzlar, 독일, 35578
- Klinikum Wetzlar-Braunfels - Klinik für Geriatrie
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Arlon, 벨기에, 6700
- Vivalia - Clinique Saint Joseph
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Brussels, 벨기에, 1090
- Universitair Ziekenhuis Brussel
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Brussels, 벨기에, 1070
- Hospital Erasme
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Brussels, 벨기에, 1200
- Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL)
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Charleroi, 벨기에, 6000
- Grand Hôpital de Charleroi
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Edegem, 벨기에, 2650
- University Hospital Antwerp
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Gent, 벨기에, 9000
- Ghent University Hospital
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Ottignies, 벨기에, 1340
- Saint-Pierre Clinic
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Tournai, 벨기에, 7500
- Hospital Center of Wallonie Picarde
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Stockholm, 스웨덴, 14186
- Karolinska University Hospital, PMI Huddinge, B31
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Barcelona, 스페인, 08907
- Hospital Universitari de Bellvitge
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Burgos, 스페인, 09006
- Hospital Universitario de Burgos
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Girona, 스페인, 17007
- Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit
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Lleida, 스페인, 25198
- Hospital Universitari Arnau de Vilanova
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Madrid, 스페인, 28031
- Hospital Universitario Infanta Leonor
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Madrid, 스페인, 28942
- Hospital Universitario de Fuenlabrada - Intensive Care Unit
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Palma de Mallorca, 스페인, 07120
- Hospital Universitari Son Espases
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Valencia, 스페인, 46010
- Hospital Clínic de Valencia
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Valladolid, 스페인, 47012
- Hospital Universitario Río Hortega
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Vigo, 스페인, 36312
- Hospital Alvaro Cunqueiro
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Liverpool, 영국, L7 8XP
- The Royal Liverpool University Hospital
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Liverpool, 영국, L14 3PE
- Liverpool Heart and Chest Hospital
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London, 영국, E1 1BB
- The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London
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Vienna, 오스트리아, 1090
- Medical University of Vienna
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Foggia, 이탈리아, 71121
- Ospedali riuniti di Foggia
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Milano, 이탈리아, 20142
- Ospedale San Paolo
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Nocera Inferiore, 이탈리아, 84014
- Ospedale Umberto I
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Ravenna, 이탈리아, 48121
- Hospital Santa Maria delle Croci
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Rimini, 이탈리아, 47900
- Ospedale Infermi Rimini
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Brno, 체코, 62500
- Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno
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Brno, 체코, 62500
- Clinic of Internal Medicine and Gastroenterology, University Hospital Brno
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Brno, 체코, 65691
- St Anne's University Hospital Brno
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Hradec Králové, 체코, 50005
- 3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Králové
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Hradec Králové, 체코, 50005
- Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové
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Hradec Králové, 체코, 50005
- III Internal Gerontometabolic Clinic, University Hospital Hradec Králové
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Olomouc, 체코, 77900
- University Hospital Olomouc Palacky University in Olomouc Faculty of Medicine and Dentistry
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Pardubice, 체코, 53003
- Hospital Pardubice Region, Inc.
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Plzen, 체코, 30460
- Charles University Hospital Plzeň
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Plzen, 체코, 30460
- University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzeň: Úvodní strana)
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Prague, 체코, 15006
- Motol University Hospital
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Prague, 체코, 12808
- General University Hospital Prague
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Ústí Nad Labem, 체코, 40011
- Masaryk Hospital
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Białystok, 폴란드, 15-276
- Uniwersytecki Szpital Kliniczny w Białymstoku
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Bydgoszcz, 폴란드, 85-001
- 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy
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Katowice, 폴란드, 40-055
- Medical University of Silesia
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Kraków, 폴란드, 31-826
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.
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Opole, 폴란드, 45-401
- Uniwersytecki Szpital Kliniczny w Opolu
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Poznań, 폴란드, 60-479
- Szpital Wojewódzki w Poznaniu
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Angers, 프랑스, 49100
- Centre hospitalier universitaire d'Angers
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Besançon, 프랑스, 25000
- Centre Hospitalier Régional Universitaire de Besançon
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Brest, 프랑스, 29200
- Hôpital de la Cavale Blanche à Brest
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Caen, 프랑스, 14000
- Hospital Center University Of Caen Normandie
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Chambray-lès-Tours, 프랑스, 37170
- Hôpital Trousseau - Surgical Intensive Care Unit
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Clermont-Ferrand, 프랑스, 63000
- Centre Hospitalier Universitaire de Clermont-Ferrand
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La Tronche, 프랑스, 38700
- Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon
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Lyon, 프랑스, 69003
- Hospices civils de Lyon - Hôpital Edouard Herriot
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Marseille, 프랑스, 13009
- Institut Paoli-Calmettes
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Saint-Étienne, 프랑스, 42000
- Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
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Suresnes, 프랑스, 92150
- Hopital Foch
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Valenciennes, 프랑스, 59300
- Centre Hospitalier de Valenciennes
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Vandœuvre-lès-Nancy, 프랑스, 54500
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
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Budapest, 헝가리, 1096
- Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology
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Budapest, 헝가리, 1134
- MH EK Honvédkorház
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Debrecen, 헝가리, 4032
- University of Debrecen - Department of Anaesthesiology and Intensive Therapy
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Nyíregyháza, 헝가리, 4400
- Jósa András Oktatókórház
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Székesfehérvár, 헝가리, 8000
- Fejér Megyei Szent György Egyetemi Oktató Kórház
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Veszprém, 헝가리, 8200
- Csolnoky Ferenc Korhaz
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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:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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adult critically ill patients
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Proportion of patients receiving enteral nutrition (EN), parenteral nutrition (PN), and oral nutrition (ON)/oral nutrition supplements (ONS)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Michael Hiesmayr, Prof. MD, Medical University of Vienna
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 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. .