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CompletedNCT04143503

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,208 (actual)
Sponsor
Fresenius Kabi · Industry
Sex
All
Age
18 Years – 95 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2019-11-05
Primary completion
2020-05-13
Completion
2020-07-30
First posted
2019-10-29
Last updated
2020-07-31

Locations

76 sites across 11 countries: Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT04143503. Inclusion in this directory is not an endorsement.

Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients (NCT04143503) · Clinical Trials Directory