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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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