Nutrient Pattern Analysis in Critically Ill Patients (NAChO) (NAChO)

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Dept of Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	days 6 to 14
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.	days 6 to 14

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	days 6 to 14
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.	days 6 to 14
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").	days 6 to 14

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Nestec Ltd.
• Investigators: Principal Investigator: Joerg C Schefold, MD, Inselspital, Bern University Hospital; Study Chair: Jukka Takala, MD, Inselspital, Bern University Hospital; Study Chair: Stephan M Jakob, MD, Inselspital, Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Asthenia
• Other Study ID Numbers: NACHO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No