Nutrient Pattern Analysis in Critically Ill Patients (NAChO)

Muscle Weakness Clinical Trial

— NAChO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839018
• Other study ID #: NAChO
• Status: Completed
• Start date: January 2017
• Est. completion date: March 20, 2020

Study information

• Verified date: March 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Switzerland	Inselspital, Dept of Intensive Care Medicine	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Nestec Ltd.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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