Nutrient Pattern Analysis in Critically Ill Patients (NAChO)

NCT02839018 | Completed

• 1 other identifier: NAChO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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")

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Nestec Ltd.: collaborator

Study Sites (1)

Inselspital, Dept of Intensive Care Medicine

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Urine, Muscle biopsy

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Joerg C Schefold, MD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Jukka Takala, MD

  Inselspital, Bern University Hospital

  STUDY CHAIR

• Stephan M Jakob, MD

  Inselspital, Bern University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: March 20, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)