NCT02839018CompletedNot Applicable
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 enrollmentStarted: January 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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.
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
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)
Investigators
Study Sites (1)
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