CompletedPhase 4ACTRN12617000384358

The effect of standard versus energy dense feeds on gastric emptying and glucose metabolism in critically ill patients


Sponsor

Intensive Care Research Unit, Royal Adelaide Hospital

Enrollment

25 participants

Start Date

May 16, 2017

Study Type

Interventional

Conditions

Summary

Enteral feeding is standard of care in critically ill patients, however delivery is often inadequate with observational studies reporting patients only receive 60% of estimated energy needs. A primary reason for inadequate nutrient delivery is delayed gastric emptying, which occurs in up to 50% of mechanically ventilated critically ill patients. While standard enteral formulas contain 1 kcal/ml, it is common practice for an energy-dense formula (2kcal/ml) to be prescribed by clinicians to enable higher caloric delivery in a smaller volume, as a way of circumventing the effects of delayed gastric emptying. However, at present there is no evidence to support the concept that use of an energy-dense formula will enable greater calorie delivery and nutrient absorption. It has been demonstrated, in health, that gastric emptying occurs at a constant rate based on caloric delivery approximating 1-4 kcal/min and rather than volume dependent. Therefore, the aim of this study is to evaluate the effect of calorie concentration on the rate of gastric emptying in critically ill patients.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Mechanically ventilated critically ill patients who are:
  • Aged >18 years of age
  • Receiving or suitable to receive enteral nutrition
  • Anticipated to remain mechanically ventilated for a further 48 hours

Exclusion Criteria6

  • Patients will be excluded if they meet one of the following:
  • Pregnancy
  • Receiving gastrokinetic drugs (including Erythromycin, Metoclopramide, Azithromycin, Domperidone, Prucalopride)
  • Gastrointestinal surgery on this admission
  • Previous upper gastrointestinal surgery (oesophageal, stomach or duodenal)
  • Unable to obtain informed consent

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Interventions

Patients will be studied on two consecutive days, in which they will receive either standard feed (1 kcal/ml) or energy dense feed (2 kcal/ml), in a randomised, double blind fashion. On each day, ente

Patients will be studied on two consecutive days, in which they will receive either standard feed (1 kcal/ml) or energy dense feed (2 kcal/ml), in a randomised, double blind fashion. On each day, enteral feeding will be ceased four hours prior to the commencement of the study. Blood glucose levels will be managed according to the Royal Adelaide Hospital Intensive Care Unit protocol i.e. <10 mmol/l. However, due to patients not receiving feeds following the test meal, exogenous insulin infusions will be ceased prior to the commencement of the test meal. Computer randomisation will be performed by a nuclear medicine technician, who will measure out the study feed and add the radioactive marker. This nuclear medicine technician will not be involved in the conduct of the study or interpretation of the results and will instill the study feed to ensure allocation concealment is maintained. At t = -5, an intragastric ‘meal’ will be infused over 5 minutes. The meal will contain 200 ml of ‘Standard’ feed (Nutrison 1kcal/ml, Nutricia Australia, containing carbohydrate 49%, fat 35%, and protein 16%, osmolality 305 mOsm/kg H2O) or 100 ml of ‘Energy dense’ feed (TwoCal 2kcal/ml, Abbott Nutrition, containing carbohydrate 43%, fat 40%, and protein 17%, osmolality 690 mOsm/kg H2O). The order in which standard or energy dense feeds are given will depend on randomisation. The meal will also contain 3 g of 3-O-Methyl-D-gluco-pyranose (3-OMG) (Sigma-Aldrich) dissolved in 5 ml H2O and 20MBq 99mTc-calcium phytate colloid. Radioisotopic data will be acquired in dynamic mode every minute for the first 60 minutes and every 3 minutes thereafter for a total of 240 minutes using a gamma camera (DigiRad 2020tc, Gammasonics) with the patient lying in the semi-recumbent position. An arterial blood sample will be obtained every 15 minutes for the first hour and every 30 minutes thereafter for measurement of blood glucose concentration, plasma GLP-1, CCK, PYY and Glucagon, and serum Insulin, C-peptide and 3-OMG. Enteral nutrition will be commenced immediately on study completion (4 hours following meal administration).


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12617000384358


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