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

NCT04143503 | Completed

• 1 other identifier: NScr-003-CNI
• Study Type: observational
• Target: 1,208
• Locations: 11 countries
• Sites: 76

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).

Conditions

Critical Illness

Keywords

ICU; parenteral nutrition; enteral nutrition; energy intake; protein intake

Outcome Measures

Primary Outcomes (6)

• 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 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)

• 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)

Study Arms (1)

adult critically ill patients

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead
• IQVIA Commercial GmbH & Co. OHG: collaborator

Study Sites (76)

Medical University of Vienna

Vienna, 1090, Austria

Location

Vivalia - Clinique Saint Joseph

Arlon, 6700, Belgium

Location

Hospital Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL)

Brussels, 1200, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

Location

University Hospital Antwerp

Edegem, 2650, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Saint-Pierre Clinic

Ottignies, 1340, Belgium

Location

Hospital Center of Wallonie Picarde

Tournai, 7500, Belgium

Location

Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno

Brno, 62500, Czechia

Location

Clinic of Internal Medicine and Gastroenterology, University Hospital Brno

Brno, 62500, Czechia

Location

St Anne's University Hospital Brno

Brno, 65691, Czechia

Location

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

Hradec Králové, 50005, Czechia

Location

Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Location

III Internal Gerontometabolic Clinic, University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Location

University Hospital Olomouc Palacky University in Olomouc Faculty of Medicine and Dentistry

Olomouc, 77900, Czechia

Location

Hospital Pardubice Region, Inc.

Pardubice, 53003, Czechia

Location

Charles University Hospital Plzen

Pilsen, 30460, Czechia

Location

University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzeň: Úvodní strana)

Pilsen, 30460, Czechia

Location

General University Hospital Prague

Prague, 12808, Czechia

Location

Motol University Hospital

Prague, 15006, Czechia

Location

Masaryk Hospital

Ústí nad Labem, 40011, Czechia

Location

Centre Hospitalier Universitaire d'Angers

Angers, 49100, France

Location

Centre Hospitalier Régional Universitaire de Besançon

Besançon, 25000, France

Location

Hôpital de la Cavale Blanche à Brest

Brest, 29200, France

Location

Hospital Center University of Caen Normandie

Caen, 14000, France

Location

Hôpital Trousseau - Surgical Intensive Care Unit

Chambray-lès-Tours, 37170, France

Location

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon

La Tronche, 38700, France

Location

Hospices Civils de Lyon - Hópital Edouard Herriot

Lyon, 69003, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Centre Hospitalier Universitaire de Saint-Étienne - Hopital Nord

Saint-Etienne, 42000, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Charité Universitätsmedizin - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin

Berlin, 13353, Germany

Location

Augusta Kliniken Bochum Hattingen

Bochum, 44791, Germany

Location

KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie

Hanover, 30459, Germany

Location

UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

Location

Klinikum St. Georg

Leipzig, 04129, Germany

Location

Klinikum der Universität München

Munich, 81377, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Klinikum Wetzlar-Braunfels - Klinik für Geriatrie

Wetzlar, 35578, Germany

Location

Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology

Budapest, 1096, Hungary

Location

MH EK Honvédkorház

Budapest, 1134, Hungary

Location

University of Debrecen - Department of Anaesthesiology and Intensive Therapy

Debrecen, 4032, Hungary

Location

Jósa András Oktatókórház

Nyíregyháza, 4400, Hungary

Location

Fejér Megyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, 8000, Hungary

Location

Csolnoky Ferenc Kórház

Veszprém, 8200, Hungary

Location

Ospedali Riuniti di Foggia

Foggia, 71121, Italy

Location

Ospedale San Paolo

Milan, 20142, Italy

Location

Ospedale Umberto I

Nocera Inferiore, 84014, Italy

Location

Hospital Santa Maria delle Croci

Ravenna, 48121, Italy

Location

Ospedale Infermi Rimini

Rimini, 47900, Italy

Location

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, 15-276, Poland

Location

10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy

Bydgoszcz, 85-001, Poland

Location

Medical University of Silesia

Katowice, 40-055, Poland

Location

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. Z o.o.

Krakow, 31-826, Poland

Location

Uniwersytecki Szpital Kliniczny w Opolu

Opole, 45-401, Poland

Location

Szpital Wojewódzki w Poznaniu

Poznan, 60-479, Poland

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit

Girona, 17007, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario de Fuenlabrada - Intensive Care Unit

Madrid, 28942, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, 07120, Spain

Location

Hospital Clinic de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

Location

Karolinska University Hospital, PMI Huddinge, B31

Stockholm, 14186, Sweden

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

The Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London

London, E1 1BB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35585554 DERIVED

• 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.

  PMID: 34024501 DERIVED

MeSH Terms

Conditions

Critical Illness; Hyperphagia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Michael Hiesmayr, Prof. MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: November 5, 2019
• Primary Completion: May 13, 2020
• Study Completion: July 30, 2020
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10); SE (1); GB (3); IT (5); BE (9); AU (1); CZ (13); HU (6); DE (9); FR (13); PL (6)