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

Completed

• Conditions: Critical Illness

• Registration Number: NCT04143503
• Lead Sponsor: Fresenius Kabi

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2019-11-05
• Primary Completion: 2020-05-13
• Status Verified: 2020-07
• Study Completion: 2020-07-30
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1208

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative caloric balance	from admission to ICU until discharge from ICU or death (maximum of 15 days)
Cumulative protein balance	from admission to ICU until discharge from ICU or death (maximum of 15 days)
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)
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)
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)
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)

Trial Locations

Locations (76)

Medical University of Vienna; 🇦🇹 Vienna, Austria

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium

Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL); 🇧🇪 Brussels, Belgium

University Hospital Antwerp; 🇧🇪 Edegem, Belgium

10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy; 🇵🇱 Bydgoszcz, Poland

University of Debrecen - Department of Anaesthesiology and Intensive Therapy; 🇭🇺 Debrecen, Hungary

Uniwersytecki Szpital Kliniczny w Białymstoku; 🇵🇱 Białystok, Poland

Csolnoky Ferenc Kórház; 🇭🇺 Veszprém, Hungary

Szpital Wojewódzki w Poznaniu; 🇵🇱 Poznań, Poland

Vivalia - Clinique Saint Joseph; 🇧🇪 Arlon, Belgium

Hospital Erasme; 🇧🇪 Brussels, Belgium

Ospedale San Paolo; 🇮🇹 Milano, Italy

Hôpital Trousseau - Surgical Intensive Care Unit; 🇫🇷 Chambray-lès-Tours, France

Centre Hospitalier de Valenciennes; 🇫🇷 Valenciennes, France

Clinic of Internal Medicine and Gastroenterology, University Hospital Brno; 🇨🇿 Brno, Czechia

University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzeň: Úvodní strana); 🇨🇿 Plzen, Czechia

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Belgium

Charité Universitätsmedizin - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Hospital Center of Wallonie Picarde; 🇧🇪 Tournai, Belgium

Jósa András Oktatókórház; 🇭🇺 Nyíregyháza, Hungary

Centre Hospitalier Universitaire d'Angers; 🇫🇷 Angers, France

Hospital Universitario de Fuenlabrada - Intensive Care Unit; 🇪🇸 Madrid, Spain

Masaryk Hospital; 🇨🇿 Ústí Nad Labem, Czechia

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Ghent University Hospital; 🇧🇪 Gent, Belgium

The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London; 🇬🇧 London, United Kingdom

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

St Anne's University Hospital Brno; 🇨🇿 Brno, Czechia

Hospital Pardubice Region, Inc.; 🇨🇿 Pardubice, Czechia

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

General University Hospital Prague; 🇨🇿 Prague, Czechia

Ospedali Riuniti di Foggia; 🇮🇹 Foggia, Italy

3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Králové; 🇨🇿 Hradec Králové, Czechia

Fejér Megyei Szent György Egyetemi Oktató Kórház; 🇭🇺 Székesfehérvár, Hungary

Ospedale Umberto I; 🇮🇹 Nocera Inferiore, Italy

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital Foch; 🇫🇷 Suresnes, France

MH EK Honvédkorház; 🇭🇺 Budapest, Hungary

Charles University Hospital Plzen; 🇨🇿 Plzen, Czechia

UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel; 🇩🇪 Kiel, Germany

Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology; 🇭🇺 Budapest, Hungary

Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno; 🇨🇿 Brno, Czechia

Medical University of Silesia; 🇵🇱 Katowice, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. Z o.o.; 🇵🇱 Kraków, Poland

Hospital Universitari Son Espases; 🇪🇸 Palma de Mallorca, Spain

Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin; 🇩🇪 Berlin, Germany

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Spain

Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové; 🇨🇿 Hradec Králové, Czechia

Centre Hospitalier Régional Universitaire de Besançon; 🇫🇷 Besançon, France

Hospital Universitario Rio Hortega; 🇪🇸 Valladolid, Spain

Motol University Hospital; 🇨🇿 Prague, Czechia

Uniwersytecki Szpital Kliniczny w Opolu; 🇵🇱 Opole, Poland

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain

The Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom

Karolinska University Hospital, PMI Huddinge, B31; 🇸🇪 Stockholm, Sweden

Hospices Civils de Lyon - Hópital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital de la Cavale Blanche à Brest; 🇫🇷 Brest, France

Hospital Center University of Caen Normandie; 🇫🇷 Caen, France

Centre Hospitalier Universitaire de Saint-Étienne - Hopital Nord; 🇫🇷 Saint-Étienne, France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois; 🇫🇷 Vandœuvre-lès-Nancy, France

Saint-Pierre Clinic; 🇧🇪 Ottignies, Belgium

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

Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon; 🇫🇷 La Tronche, France

Augusta Kliniken Bochum Hattingen; 🇩🇪 Bochum, Germany

KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie; 🇩🇪 Hannover, Germany

Klinikum St. Georg; 🇩🇪 Leipzig, Germany

Klinikum der Universität München; 🇩🇪 Munich, Germany

Klinikum Wetzlar-Braunfels - Klinik für Geriatrie; 🇩🇪 Wetzlar, Germany

Ospedale Infermi Rimini; 🇮🇹 Rimini, Italy

Hospital Santa Maria delle Croci; 🇮🇹 Ravenna, Italy

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit; 🇪🇸 Girona, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Clinic de Valencia; 🇪🇸 Valencia, Spain