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Completed

NCT Number: NCT02839018

Nutrient Pattern Analysis in Critically Ill Patients (NAChO)

Little is known about nutritional Parameters that potentially influence the course of intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the nutritional profiles in blood, urine and muscle in respective patients at risk.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Dept of Intensive Care Medicine

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Written informed consent obtained from the patient's legal representative and later from the patients (as soon as possible)
  • Individuals diagnosed with severe head trauma or intracerebral hemorrhage ("central nervous system group") or with severe sepsis/ septic shock ("Sepsis group") at any time from ICU admission until day 5 (i.e. day of screening)
  • Patient on the ICU for ≥ 5 days ("ICU long stayer")

Exclusion criteria

  • Language other than German or French
  • Institutionalized Individuals (e.g. prisoners, severe pre-existing mental incapacity)
  • Patients with known pre-existing neurological or psychiatric disease that will make informed consent likely impossible
  • Patients with known pregnancy or known to be lactating will not be included to the investigation. Due to the observational/ diagnostical nature of the study, a pregnancy test will not be performed.
  • Patients on extracorporeal membrane oxygenation (ECMO)
  • Clinical signs of pre-existing malnutrition (Body mass index <18)
  • Pre-existing evidence for history of anorexia or bulimia
  • Parenteral nutrition received within last 5 days (for more than 12 hours) or evidence for parental nutrition needed within next 7 days
  • Terminal disease (i.e. life expectancy <14 days)
  • Patients with active malignancy
  • Patients on biologicals interfering with metabolism (e.g. infliximab)
  • Patients on chronic steroid medication (i.e. prednisone equivalent dose >10mg/day)
  • Patients on neuromuscular blocking agents on a regular basis (i.e. on a repetitive basis within last 48 hours or evidence for need within next 7 days)
  • At screening (day 5): prescribed caloric intake substantially higher (i.e. > 150% of caloric need of indirect calorimetry) than indirect calorimetric results (in intubated patients) or i.e. standard-of-care (25 Kcal/kg body weight/day)
  • Severe adipositas defined as BMI >40
  • Known pre-existing allergy to standard enteral formulae
  • Subject previously enrolled to an interventional trial that is not considered standard-of-care (e.g. investigation of new medication/drug or medical devices)

Treatment and study plan

Primary outcomes

  1. Differences in blood nutrient levels over time in patients with/without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6.

    Time frame: days 6 to 14

  2. Differences in blood nutrient levels over time in patients in "sepsis group" vs. "CNS group". Primary comparison of interest is between day 14 vs. day 6.

    Time frame: days 6 to 14

Secondary outcomes

  1. Differences in urine nutrient levels over time in patients with/ without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6.

    Time frame: days 6 to 14

  2. Differences in urine nutrient levels over time in patients in "sepsis group" vs. "CNS group". Primary comparison of interest is between day 14 vs. day 6.

    Time frame: days 6 to 14

  3. Subgroup analysis: differences in nutrient levels at day 14 vs. day 6 in muscle biopsy samples of ICU long stayer patients in study groups (i.e. "ICU-AW" vs. "no-ICU-AW" and "Sepsis" vs. "CNS").

    Time frame: days 6 to 14

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Nestec Ltd.

Registry information

Official study title

Nutrient Pattern Analysis in Critically Ill Patients Using Omics Technology (NAChO): A Prospective Single-center Observational Trial

Acronym: NAChO

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 20, 2016
Registry last updated
Mar 23, 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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