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Critical IllnessNCT04143503

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

An observational study of Critical Illness, run by Fresenius Kabi at 76 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Critical Illness
How many people
1,208 participants
Where
76 sitesin 11 countries
Study dates
5 Nov 2019to 30 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

76 sites in 11 countries.

76 sites in 11 countries

Czechia13 sites

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

    Brno, 62500

  • Clinic of Internal Medicine and Gastroenterology, University Hospital Brno

    Brno, 62500

  • St Anne's University Hospital Brno

    Brno, 65691

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

    Hradec Králové, 50005

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

    Hradec Králové, 50005

  • III Internal Gerontometabolic Clinic, University Hospital Hradec Králové

    Hradec Králové, 50005

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

    Olomouc, 77900

  • Hospital Pardubice Region, Inc.

    Pardubice, 53003

  • Charles University Hospital Plzen

    Pilsen, 30460

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

    Pilsen, 30460

  • General University Hospital Prague

    Prague, 12808

  • Motol University Hospital

    Prague, 15006

  • Masaryk Hospital

    Ústí nad Labem, 40011

Other trials in Czechia

France13 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49100

  • Centre Hospitalier Régional Universitaire de Besançon

    Besançon, 25000

  • Hôpital de la Cavale Blanche à Brest

    Brest, 29200

  • Hospital Center University of Caen Normandie

    Caen, 14000

  • Hôpital Trousseau - Surgical Intensive Care Unit

    Chambray-lès-Tours, 37170

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, 63000

  • Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon

    La Tronche, 38700

  • Hospices Civils de Lyon - Hópital Edouard Herriot

    Lyon, 69003

  • Institut Paoli-Calmettes

    Marseille, 13009

  • Centre Hospitalier Universitaire de Saint-Étienne - Hopital Nord

    Saint-Etienne, 42000

  • Hôpital Foch

    Suresnes, 92150

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59300

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Spain10 sites

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit

    Girona, 17007

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario de Fuenlabrada - Intensive Care Unit

    Madrid, 28942

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Hospital Clinic de Valencia

    Valencia, 46010

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

  • Hospital Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Belgium9 sites

  • Vivalia - Clinique Saint Joseph

    Arlon, 6700

  • Hospital Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

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

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • University Hospital Antwerp

    Edegem, 2650

  • Ghent University Hospital

    Ghent, 9000

  • Saint-Pierre Clinic

    Ottignies, 1340

  • Hospital Center of Wallonie Picarde

    Tournai, 7500

Other trials in Belgium

Germany9 sites

  • Charité Universitätsmedizin - Campus Benjamin Franklin

    Berlin, 12203

  • Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin

    Berlin, 13353

  • Augusta Kliniken Bochum Hattingen

    Bochum, 44791

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

    Hanover, 30459

  • UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105

  • Klinikum St. Georg

    Leipzig, 04129

  • Klinikum der Universität München

    Munich, 81377

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Klinikum Wetzlar-Braunfels - Klinik für Geriatrie

    Wetzlar, 35578

Other trials in Germany

Hungary6 sites

  • Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology

    Budapest, 1096

  • MH EK Honvédkorház

    Budapest, 1134

  • University of Debrecen - Department of Anaesthesiology and Intensive Therapy

    Debrecen, 4032

  • Jósa András Oktatókórház

    Nyíregyháza, 4400

  • Fejér Megyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár, 8000

  • Csolnoky Ferenc Kórház

    Veszprém, 8200

Other trials in Hungary

Poland6 sites

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok, 15-276

  • 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy

    Bydgoszcz, 85-001

  • Medical University of Silesia

    Katowice, 40-055

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

    Krakow, 31-826

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, 45-401

  • Szpital Wojewódzki w Poznaniu

    Poznan, 60-479

Other trials in Poland

Italy5 sites

  • Ospedali Riuniti di Foggia

    Foggia, 71121

  • Ospedale San Paolo

    Milan, 20142

  • Ospedale Umberto I

    Nocera Inferiore, 84014

  • Hospital Santa Maria delle Croci

    Ravenna, 48121

  • Ospedale Infermi Rimini

    Rimini, 47900

Other trials in Italy

United Kingdom3 sites

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE

  • The Royal Liverpool University Hospital

    Liverpool, L7 8XP

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

    London, E1 1BB

Other trials in United Kingdom

Austria1 site

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Sweden1 site

  • Karolinska University Hospital, PMI Huddinge, B31

    Stockholm, 14186

Other trials in Sweden

About this study

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

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).

Keywords
ICU, parenteral nutrition, enteral nutrition, energy intake, protein intake
Medical subject headings
Critical Illness, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04143503
Study groupRoleWhat they receive
adult critically ill patientsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients receiving enteral nutrition (EN), parenteral nutrition (PN), and oral nutrition (ON)/oral nutrition supplements (ONS)

    Measured: from admission to ICU until discharge from ICU or death (maximum of 15 days)

  2. Cumulative caloric balance

    Measured: from admission to ICU until discharge from ICU or death (maximum of 15 days)

  3. Cumulative protein balance

    Measured: from admission to ICU until discharge from ICU or death (maximum of 15 days)

  4. 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

    Measured: from admission to ICU until discharge from ICU or death (maximum of 15 days)

  5. Cumulative protein (g/kg and total g) administered via EN, PN, ON/ONS, and via all sources combined

    Measured: from admission to ICU until discharge from ICU or death (maximum of 15 days)

  6. Proportion of patients with interrupted/stopped or not started clinical nutrition

    Measured: from admission to ICU until discharge from ICU or death (maximum of 15 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start5 Nov 2019
  3. Primary completion13 May 2020
  4. Study completion30 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143503
Sponsor's protocol ID
NScr-003-CNI
Status last verified
Jul 2020
First submitted
25 Oct 2019
Last updated
31 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35585554

  • 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.

    PubMed 34024501

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness, run by Fresenius Kabi at 76 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Czechia, France, Spain, Belgium, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients receiving enteral nutrition (EN), parenteral nutrition (PN), and oral nutrition (ON)/oral nutrition supplements (ONS) (time frame: from admission to ICU until discharge from ICU or death (maximum of 15 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143503, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.

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