Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insuli… (NCT02503527) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy
Stopped: Low Recruitment rate
Austria28 participantsStarted 2015-08
Plain-language summary
The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically ill patients receiving insulin treatment for blood glucose management.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: ALA…
What they're measuring
1
Blood glucose variability (within patient standard deviation of blood glucose values per day)
Timeframe: At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first