Clinical trial NCT02839018: Nutrient Pattern Analysis in Critically Ill Patients (NAChO)
Official title: Nutrient Pattern Analysis in Critically Ill Patients Using Omics Technology (NAChO): A Prospective Single-center Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)
Muscle Weakness
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Nestec Ltd.
First posted: 2016-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill patients with severe Sepsis/shock ("Sepsis Group") or intracerebral conditions (CNS Group)

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: days 6 to 14
measure: 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.
timeFrame: days 6 to 14
Secondary outcomes:
measure: 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.
timeFrame: days 6 to 14
measure: 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.
timeFrame: days 6 to 14
measure: 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").
timeFrame: days 6 to 14
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Dept of Intensive Care Medicine
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Joerg C Schefold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inselspital, Bern University Hospital
name: Jukka Takala, MD
role: STUDY_CHAIR
affiliation: Inselspital, Bern University Hospital
name: Stephan M Jakob, MD
role: STUDY_CHAIR
References: