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Glucerna in Critically ill Patients (GluCip trial): Investigating the glycaemic effects of a reduced-carbohydrate, modified-fat, fiber-containing enteral formula (Glucerna®) in critically ill patients.

Glucerna in Critically ill Patients (GluCip trial): Investigating the glycaemic effects of a reduced-carbohydrate, modified-fat, fiber-containing enteral formula (Glucerna®) in critically ill patients. - GluCip Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42200
Enrollment
90
Registered
2015-04-14
Start date
2015-09-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes glucose variability stress-hyperglycaemia

Interventions

Subjects will be randomized to either Glucerna® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding, or Fresubin® Energy Fibre (Fresenius, UK

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years Patients with an anticipated stay of at least 24 hours of admission to the intensive care Expected to receive enteral feeding for at least 72 hours Indication for glucose regulation with insulin (according to the current glucose treatment protocol) Patient or surrogate understands and signs informed consent document

Exclusion criteria

Exclusion criteria: Patients with pre-existing contraindications to enteral feeding or to placement of a CGM system Patients previously randomised into the GluCip trial Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the extent of glucose variability, defined as the mean absolute glucose (MAG) change (delta glucose/delta time) in mmol/l/hr, measured by continuous glucose monitoring technology.

Secondary

MeasureTime frame
Secondary outcomes include: time in target range (between 6-9 mmol/l) and below and above target range, mean (sensor) glucose, standard deviation of glucose values, severe hypo- and hyperglycaemic events ( 15.0 mmol/l), amount of insulin use, daily nutritional administration, clinical gastrointestinal symptoms.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)