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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT02503527
Eligibility Criteria:
Inclusion Criteria:
* Patients with spontaneous aneurysmal subarachnoid hemorrhage (SAH) defined according to Hunt and Hess scale grade HH5
* Requiring mechanical ventilation in the ICU at the time of enrolment
* Enteral nutrition (EN) in the ICU at time of enrolment
* If enrolment on day 3 of ICU stay, EN equal to or larger than 80% of total calories in case of supplementary parenteral nutrition (PN) with anticipated 100% EN as of day 4 to 8 of ICU stay
* If enrolment on day 4 of ICU stay, 100% EN planned for at least 5 days from the time of enrolment
* Patients expected to stay in the ICU for at least 5 days following enrolment
* Age 18 - 75 years
* Glycemic control with intravenous insulin therapy to maintain a target glucose range between 110 mg/dL and 150 mg/dL (6.1 and 8.3 mmol/l)
* Informed consent according to local regulations for decisionally impaired subjects
Exclusion Criteria:
* Patients with septic shock at time of enrolment
* Participation in a clinical trial with any investigational product within 4 weeks before study
* Patients requiring a fibre free diet
* Total or supplementary parenteral nutrition (\> 20% of total calories)
* Known or suspected intolerance or allergy to any component of the study product(s), e.g. galactosemia
* Gastrectomy
* Postpyloric nutrition
* Any clinical condition not allowing enteral nutrition (e.g. emesis, severe reflux, severe diarrhea)
* Known severe heart failure (NYHA class 4)
* Liver insufficiency / failure (male: ALAT \> 150 U/l; female: ALAT \> 120 U/l)
* Acute kidney failure (blood creatinine \> 2.5 mg/dl)
* Body Mass Index \< 18 or \> 35 kg/m²
* Known or suspicion of drug abuse
* Pregnant or breast feeding women
* Patients with diabetes mellitus type I
Exclusion After Enrolment (Withdrawal of Subjects)
* Start of PN with more than 20% of total given energy amount/ day
* Insulin infusion stopped unexpectedly for \> 12h for non-nutritional reasons
* Discharge from ICU
* Intolerable AEs
* Major protocol violation
* Withdrawal of informed consent
* Discontinuation of study treatment for other reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02503527
Study Brief:
Protocol Section:
NCT02503527