Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143503
• Other study ID #: NScr-003-CNI
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Critical Illness

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	Vandœuvre-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)