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NCT Number: NCT04143503

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

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).

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Key information

Conditions

Critical Illness Disease Attributes Hyperphagia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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)

  2. Cumulative caloric balance

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

  3. Cumulative protein balance

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Collaborators

  • IQVIA Commercial GmbH & Co. OHG

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2019
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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