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CompletedNCT02839018NAChOUpdated Mar 23, 2020

Nutrient Pattern Analysis in Critically Ill Patients (NAChO)

An observational study in Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) and Muscle Weakness, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-23.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)
  • Muscle Weakness
03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's enrollment of 100 is close to the median of 98 across 144 observational studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

critically ill patients with severe Sepsis/shock ("Sepsis Group") or intracerebral conditions (CNS Group)

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

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)
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Central nervous system (CNS) group

    n=50 patients with presumed low prevalence of ICU-AW

  • Severe sepsis/shock group

    n=50 patients with presumed high prevalence of ICU-AW

06

What researchers measure

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

07

Study locations

1 site
  • Inselspital, Dept of Intensive Care Medicine
    Bern, 3010, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02839018
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Nestec Ltd.
Responsible party
Sponsor
First posted
Jul 20, 2016
Start date
Jan 2017
Primary completion
Jan 2019
Completion
Mar 20, 2020
Last update
Mar 23, 2020

Study contacts

Joerg C Schefold, MD
principal investigator · Inselspital, Bern University Hospital
Jukka Takala, MD
study chair · Inselspital, Bern University Hospital
Stephan M Jakob, MD
study chair · Inselspital, Bern University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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