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

NCT04143503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1208

Last updated 2020-07-31

No results posted yet for this study

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

Sponsors & Collaborators

  • IQVIA Commercial GmbH & Co. OHG

    collaborator INDUSTRY

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Michael Hiesmayr, Prof. MD · Medical University of Vienna

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2020-05-13
Completion
2020-07-30

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04143503 on ClinicalTrials.gov