Critical illness, severly ill severly ill
Conditions
Interventions
Patients will be randomised to receive either intermittent tube feeding during 
the day (4 times delivered in 1 hour, e.g. at 08:00, 12:00, 16:00, and 20:00h
 
INT) or continuous for 24 h (total needed volume spread evenly per hour over 24 
h e.g. 50 mL/hr for 24 h
CON). The amount of nutrition patients will receive 
is based on their requirements according to standard nutritional practices.
Sponsors
Ziekenhuis Gelderse Vallei
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. Receiving or eligible to receive exclusively gastric tube feeding 3. Expected ICU stay >=48 hours 4. Receiving or anticipated to receive invasive mechanical ventilation within 48 hours after ICU admission and with an expected duration of >48 hours.
Exclusion criteria
Exclusion criteria: 1. The treating clinician considers participation in the study clinically contraindicated (e.g., change in feeding regimen, no possibility for placement of CGM on arms, not able to receive exclusive gastric tube feeding) 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. Pregnancy 4. Expected fasting in the next 12 hours, for example, due to surgery 5. Readmission in last 14 days 6. Patients with burn injuries 7. Patients who are participating in a nutrition intervention study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the between-group difference in glycaemic variability during ICU admission measured with Continuous Glucose Monitoring (CGM) expressed as Coefficient of Variation (COV). This COV is calculated by dividing the standard deviation by the mean blood glucose level and multiplying by 100. It gives a relative measure of variability, which is helpful in comparing variability between individuals or groups with different mean glucose levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycaemic control (assessed by CGM and retrospectively extracted from patient records):Mean interstitial glucose concentrations per study day (mmol/L)SD of mean interstitial glucose concentrations per study dayMean insulin dose (IU/day)Mean Amplitude of Glucose Excursions per study day (MAGE)Mean serum insulin concentrations (µU/mL/24h)HbA1c at admission (%)Number of hypoglycaemic events per study day (blood glucose level <4.0 mmol/L) Number of hyperglycaemic events per study day (blood glucose level >10.0 mmol/L) Gastrointestinal tolerance (assessed as part of clinical practice, retrospectively extracted from patient records):Gastric residual volumes (mL), total per study day and largest volume per study dayIncidence of vomiting, diarrhoea, constipation, and regurgitation per calendar day Marker of inflammation (extracted from patient records):CRP at admission, (plasma, mg/L) Circadian rhythm, sleep quality, and delirium (assessed from blood samples, saliva samples, questionnaire and extracted from patient records):Melatonin and cortisol levels obtained at 4 time points (06:00, 14:00, 18:00, 02:00) at T1 and T2 in salivamRNA expression of essential clock genes (BMAL, CLOCK, Cry1 and, Per2) obtained at 4 time points (06:00, 14:00, 18:00, 02:00) on T1 and T2 in bloodCore body temperature per calendar day (°C, mean, highest and lowest value/24h)Heart rate (bpm)*Blood pressure (mmHg)*Richmond Agitation Sedation Scale (RASS) score per calendar day (mean, highest and lowest)Glasgow Coma Scale (GCS) score per calendar day (mean, highest and lowest)Delirium Observation Screening (DOS) scale per calendar dayConfusion Assessment Method for the ICU (CAM-ICU) scores per calendar day Sleep quality measured with the Pittsburgh Sleep Quality Index (PSQI) at T=3 *Is only collected in ZGVIf available in participating centre, muscle cross sectional area and lean body mass (assessed by muscle ultrasound | — |
Countries
Netherlands
Contacts
Public ContactS.W. Beek
Wageningen Universiteit
Outcome results
None listed