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

Insel Gruppe AG, University Hospital Bern1 site in 1 country100 target enrollmentJanuary 2017

ConditionsIntensive Care Unit (ICU) Acquired Weakness (ICU - AW)Muscle Weakness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)
Sponsor: Insel Gruppe AG, University Hospital Bern
Enrollment: 100
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

March 20, 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Insel Gruppe AG, University Hospital Bern

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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)
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)
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)