Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02839018
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
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02839018
Study Brief:
Protocol Section:
NCT02839018