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The effect of continuous versus intermittent delivery of enteral feeding on glycaemic control and gastrointestinal response in critically ill patients (CGM-ICU)

The effect of continuous versus intermittent delivery of enteral feeding on glycaemic control and gastrointestinal response in critically ill patients (CGM-ICU)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000917932
Acronym
CGM-ICU
Enrollment
65
Registered
2020-09-17
Start date
2020-10-19
Completion date
2022-03-15
Last updated
2023-01-16

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

Conditions

None listed

Brief summary

This study aims to compare the effect of nutritional feeding pattern of standard feeding (continuous delivery of feeding over 24 hours) or intermittent feeding (4 boluses of feed every 6 hours) on blood glucose levels, the rate of stomach emptying and clinical outcomes. When patients are sedated and on a breathing machine in the intensive care unit (ICU) they are fed via a tube with liquid feed. Delivery of feed to critically ill patients is often provided continuously over the day as it is believed that this pattern may help control blood glucose levels and is easier logistically. However, intermittent feeding, by providing several larger boluses at 4-6 hourly intervals, follows more of a meal-like pattern, and is thought to have benefits on gut function and prevention of muscle loss. At this time, little is currently known about which pattern of feeding has the most benefit on blood glucose control, gut function and muscle mass.

Interventions

CGM-ICU study aims to assess the impact of nutrient delivery pattern (continuous versus intermittent) over a 24-hour period on glycaemic control and gastrointestinal function in enterally fed critically ill patients. A total of 60 ICU patients will be included from the intensive care unit at the Royal Adelaide Hospital. Participants will be randomised to receive a total of 1200 mL of enteral nutrition (EN) gastrically either as intermittent (4 boluses per 24 hours, therefore one bolus of 300 mL

CGM-ICU study aims to assess the impact of nutrient delivery pattern (continuous versus intermittent) over a 24-hour period on glycaemic control and gastrointestinal function in enterally fed critically ill patients. A total of 60 ICU patients will be included from the intensive care unit at the Royal Adelaide Hospital. Participants will be randomised to receive a total of 1200 mL of enteral nutrition (EN) gastrically either as intermittent (4 boluses per 24 hours, therefore one bolus of 300 mL/hr every 6 hours; INT) or continuous (total volume spread evenly per hour over 24 hours, therefore 50 mL/hr for 24 hours; CON). Throughout the study arterial blood samples will be collected every 6 hours via an arterial line present for standard care (t=0, 6, 12, and 24 h relative to the initiation of the study). Continuous interstitial glucose concentrations will be measured using a subcutaneous continuous glucose monitor. Postprandial responses will be determined from blood samples taken every 6 hours to assess plasma amino acid profiles, glucose and insulin concentrations, and key gut related-hormone concentrations (GLP-1, GIP, PYY, CCK, C-peptide, glucagon, leptin, and ghrelin). On the following day, 20 of the included patients will be assessed in a sub study (duration 4 hours), to measure gastric emptying and nutrient absorption following 24 hours of either INT or CON feeding. Patients will be selected if they meet the additional inclusion criteria: Expected to remain ventilated and receiving enteral nutrition, not receiving gastro-kinetic drugs, no prior upper gastrointestinal surgery and no gastrointestinal surgery on this admission. The 4 hour sub study involves measurement of Gastric Emptying (GE), using bedside scintigraphy, and glucose absorption (3-OMG concentrations). Patients will be provided with a 100 mL dose of enteral formulation (same EN as CON and INT feeding) labelled with 20 MBq 99mTc-calcium phytate colloid, and 3g of 3-O-Methyl-D-gluco-pyranose (3-OMG) (a non-absorbable glucose analogue). Scintigraphic images will be acquired at 1-min intervals for 60 min, and 3-min intervals thereafter for a total of 4 hours. Arterial blood samples will be taken starting at t= -5 mins, then every 15 minutes for the first hour (t= 15, 30, 45, 60 min), and half hourly for the remaining 3 hours (t= 90min – 240min).

Sponsors

Royal Adelaide Hospital.
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults (greater than or equal to 18 years) 2. Admitted to Royal Adelaide Hospital (RAH) ICU 3. Receiving or eligible to receive gastric enteral nutrition 4. Expected to be receiving enteral nutrition in ICU until at least the day after tomorrow. 5. Mechanically ventilated 6. Gastrokinetic medications will be held during the study as appropriate in consultation with treating clinician Additional inclusion into the sub-study (day 1) (Subset of 20 patients): 1. Expected to be ventilated for >48 hours (At day -1) 2. Expected to be receiving enteral nutrition for >48 hours (At day -1)

Exclusion criteria

1. Treating clinician considers intermittent feeding to be clinically contraindicated (continuous feeding is current practice in the RAH ICU) 2. Death is deemed to be imminent or inevitable during admission and the attending doctor, patient, or substitute decision maker is not committed to active treatment. 3. Diagnosed Diabetes Mellitus (type 1 and type 2) 4. Pregnancy 5. Receiving dialysis Additional exclusion into sub-study (day 1) (Subset of 20 patients): 1. Gastrointestinal surgery on this admission 2. Previous upper gastrointestinal surgery (oesophageal, stomach or duodenal)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026