Clinical trial NCT04143503: Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: ICU
parenteral nutrition
enteral nutrition
energy intake
protein intake
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
Collaborators: name: IQVIA Commercial GmbH & Co. OHG
First posted: 2019-10-29
Enrollment: 1208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤95 years, male or female
2. 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
3. BMI ≥18.5 kg/m2 and ≤45 kg/m2
4. Written informed consent or requirements of local/national ethical committee

Exclusion Criteria:

1. Burn injury
2. Pre-existing neuromuscular or psychiatric disorders that preclude proper assessment of functional status
3. 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
4. Receiving home parenteral nutrition at the time of ICU admission (e.g. due to short bowel syndrome)
5. Receiving home enteral nutrition (tube feeding) at the time of ICU admission
6. Chronic invasive or chronic non-invasive ventilatory support before ICU admission
7. Patients with a legal representative in place before ICU admission
8. Admission to the ICU for palliative care
9. 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)
10. Concurrent enrolment in a nutrition-related interventional study at the time of screening

Primary outcomes:
measure: Proportion of patients receiving enteral nutrition (EN), parenteral nutrition (PN), and oral nutrition (ON)/oral nutrition supplements (ONS)
timeFrame: from admission to ICU until discharge from ICU or death (maximum of 15 days)
measure: Cumulative caloric balance
timeFrame: from admission to ICU until discharge from ICU or death (maximum of 15 days)
measure: Cumulative protein balance
timeFrame: from admission to ICU until discharge from ICU or death (maximum of 15 days)
measure: 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
timeFrame: from admission to ICU until discharge from ICU or death (maximum of 15 days)
measure: Cumulative protein (g/kg and total g) administered via EN, PN, ON/ONS, and via all sources combined
timeFrame: from admission to ICU until discharge from ICU or death (maximum of 15 days)
measure: Proportion of patients with interrupted/stopped or not started clinical nutrition
timeFrame: from admission to ICU until discharge from ICU or death (maximum of 15 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Arlon
country: Belgium
facility: Vivalia - Clinique Saint Joseph
city: Brussels
country: Belgium
facility: Hospital Erasme
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Brussels
country: Belgium
facility: Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL)
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Ottignies
country: Belgium
facility: Saint-Pierre Clinic
city: Tournai
country: Belgium
facility: Hospital Center of Wallonie Picarde
city: Brno
country: Czechia
facility: Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno
city: Brno
country: Czechia
facility: Clinic of Internal Medicine and Gastroenterology, University Hospital Brno
city: Brno
country: Czechia
facility: St Anne's University Hospital Brno
city: Hradec Králové
country: Czechia
facility: 3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Králové
city: Hradec Králové
country: Czechia
facility: Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové
city: Hradec Králové
country: Czechia
facility: III Internal Gerontometabolic Clinic, University Hospital Hradec Králové
city: Olomouc
country: Czechia
facility: University Hospital Olomouc Palacky University in Olomouc Faculty of Medicine and Dentistry
city: Pardubice
country: Czechia
facility: Hospital Pardubice Region, Inc.
city: Plzen
country: Czechia
facility: Charles University Hospital Plzen
city: Plzen
country: Czechia
facility: University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzeň: Úvodní strana)
city: Prague
country: Czechia
facility: General University Hospital Prague
city: Prague
country: Czechia
facility: Motol University Hospital
city: Ústí Nad Labem
country: Czechia
facility: Masaryk Hospital
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Brest
country: France
facility: Hôpital de la Cavale Blanche à Brest
city: Caen
country: France
facility: Hospital Center University of Caen Normandie
city: Chambray-lès-Tours
country: France
facility: Hôpital Trousseau - Surgical Intensive Care Unit
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hópital Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Étienne - Hopital Nord
city: Suresnes
country: France
facility: Hôpital Foch
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
city: Berlin
country: Germany
facility: Charité Universitätsmedizin - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin
city: Bochum
country: Germany
facility: Augusta Kliniken Bochum Hattingen
city: Hannover
country: Germany
facility: KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie
city: Kiel
country: Germany
facility: UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel
city: Leipzig
country: Germany
facility: Klinikum St. Georg
city: Munich
country: Germany
facility: Klinikum der Universität München
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Wetzlar
country: Germany
facility: Klinikum Wetzlar-Braunfels - Klinik für Geriatrie
city: Budapest
country: Hungary
facility: Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology
city: Budapest
country: Hungary
facility: MH EK Honvédkorház
city: Debrecen
country: Hungary
facility: University of Debrecen - Department of Anaesthesiology and Intensive Therapy
city: Nyíregyháza
country: Hungary
facility: Jósa András Oktatókórház
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Egyetemi Oktató Kórház
city: Veszprém
country: Hungary
facility: Csolnoky Ferenc Kórház
city: Foggia
country: Italy
facility: Ospedali Riuniti di Foggia
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Nocera Inferiore
country: Italy
facility: Ospedale Umberto I
city: Ravenna
country: Italy
facility: Hospital Santa Maria delle Croci
city: Rimini
country: Italy
facility: Ospedale Infermi Rimini
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
city: Bydgoszcz
country: Poland
facility: 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. Z o.o.
city: Opole
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Opolu
city: Poznań
country: Poland
facility: Szpital Wojewódzki w Poznaniu
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada - Intensive Care Unit
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Valencia
country: Spain
facility: Hospital Clinic de Valencia
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, PMI Huddinge, B31
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London
Study officials:
affiliation: Medical University of Vienna
name: Michael Hiesmayr, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.