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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04143503
Other study ID # NScr-003-CNI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 5, 2019
Est. completion date July 30, 2020

Study information

Verified date July 2020
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 1208
Est. completion date July 30, 2020
Est. primary completion date May 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Medical University of Vienna Vienna
Belgium Vivalia - Clinique Saint Joseph Arlon
Belgium Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL) Brussels
Belgium Hospital Erasme Brussels
Belgium Universitair Ziekenhuis Brussel Brussels
Belgium Grand Hôpital de Charleroi Charleroi
Belgium University Hospital Antwerp Edegem
Belgium Ghent University Hospital Gent
Belgium Saint-Pierre Clinic Ottignies
Belgium Hospital Center of Wallonie Picarde Tournai
Czechia Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno Brno
Czechia Clinic of Internal Medicine and Gastroenterology, University Hospital Brno Brno
Czechia St Anne's University Hospital Brno Brno
Czechia 3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Králové Hradec Králové
Czechia Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové Hradec Králové
Czechia III Internal Gerontometabolic Clinic, University Hospital Hradec Králové Hradec Králové
Czechia University Hospital Olomouc Palacky University in Olomouc Faculty of Medicine and Dentistry Olomouc
Czechia Hospital Pardubice Region, Inc. Pardubice
Czechia Charles University Hospital Plzen Plzen
Czechia University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzen: Úvodní strana) Plzen
Czechia General University Hospital Prague Prague
Czechia Motol University Hospital Prague
Czechia Masaryk Hospital Ústí Nad Labem
France Centre Hospitalier Universitaire d'Angers Angers
France Centre Hospitalier Régional Universitaire de Besançon Besançon
France Hôpital de la Cavale Blanche à Brest Brest
France Hospital Center University of Caen Normandie Caen
France Hôpital Trousseau - Surgical Intensive Care Unit Chambray-lès-Tours
France Centre Hospitalier Universitaire de Clermont-Ferrand Clermont-Ferrand
France Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon La Tronche
France Hospices Civils de Lyon - Hópital Edouard Herriot Lyon
France Institut Paoli-Calmettes Marseille
France Centre Hospitalier Universitaire de Saint-Étienne - Hopital Nord Saint-Étienne
France Hôpital Foch Suresnes
France Centre Hospitalier de Valenciennes Valenciennes
France Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois VandÅ“uvre-lès-Nancy
Germany Charité Universitätsmedizin - Campus Benjamin Franklin Berlin
Germany Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin Berlin
Germany Augusta Kliniken Bochum Hattingen Bochum
Germany KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie Hannover
Germany UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel Kiel
Germany Klinikum St. Georg Leipzig
Germany Klinikum der Universität München Munich
Germany Robert-Bosch-Krankenhaus Stuttgart
Germany Klinikum Wetzlar-Braunfels - Klinik für Geriatrie Wetzlar
Hungary Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology Budapest
Hungary MH EK Honvédkorház Budapest
Hungary University of Debrecen - Department of Anaesthesiology and Intensive Therapy Debrecen
Hungary Jósa András Oktatókórház Nyíregyháza
Hungary Fejér Megyei Szent György Egyetemi Oktató Kórház Székesfehérvár
Hungary Csolnoky Ferenc Kórház Veszprém
Italy Ospedali Riuniti di Foggia Foggia
Italy Ospedale San Paolo Milano
Italy Ospedale Umberto I Nocera Inferiore
Italy Hospital Santa Maria delle Croci Ravenna
Italy Ospedale Infermi Rimini Rimini
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok
Poland 10 Wojskowy Szpital Kliniczny z Poliklinika w Bydgoszczy Bydgoszcz
Poland Medical University of Silesia Katowice
Poland Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. Z o.o. Kraków
Poland Uniwersytecki Szpital Kliniczny w Opolu Opole
Poland Szpital Wojewódzki w Poznaniu Poznan
Spain Hospital Universitari de Bellvitge Barcelona
Spain Hospital Universitario de Burgos Burgos
Spain Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit Girona
Spain Hospital Universitari Arnau de Vilanova Lleida
Spain Hospital Universitario de Fuenlabrada - Intensive Care Unit Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitari Son Espases Palma de Mallorca
Spain Hospital Clinic de Valencia Valencia
Spain Hospital Universitario Rio Hortega Valladolid
Spain Hospital Alvaro Cunqueiro Vigo
Sweden Karolinska University Hospital, PMI Huddinge, B31 Stockholm
United Kingdom Liverpool Heart and Chest Hospital Liverpool
United Kingdom The Royal Liverpool University Hospital Liverpool
United Kingdom The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London London

Sponsors (2)

Lead Sponsor Collaborator
Fresenius Kabi IQVIA Commercial GmbH & Co. OHG

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  France,  Germany,  Hungary,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients receiving enteral nutrition (EN), parenteral nutrition (PN), and oral nutrition (ON)/oral nutrition supplements (ONS) from admission to ICU until discharge from ICU or death (maximum of 15 days)
Primary Cumulative caloric balance from admission to ICU until discharge from ICU or death (maximum of 15 days)
Primary Cumulative protein balance from admission to ICU until discharge from ICU or death (maximum of 15 days)
Primary 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 from admission to ICU until discharge from ICU or death (maximum of 15 days)
Primary Cumulative protein (g/kg and total g) administered via EN, PN, ON/ONS, and via all sources combined from admission to ICU until discharge from ICU or death (maximum of 15 days)
Primary Proportion of patients with interrupted/stopped or not started clinical nutrition from admission to ICU until discharge from ICU or death (maximum of 15 days)
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