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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Wageningen University and Research | OTHER |
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The goal of this clinical trial is to investigate the effect of continuous versus intermittent enteral nutrition on metabolic outcomes in critically ill adult patients.
The aim of this study is to:
• To assess the effect of a daytime intermittent tube feeding pattern compared to standard continuous tube feeding on glycaemic control, gastrointestinal function, gastrointestinal hormones, markers of sleep quality and circadian rhythm, and lean body mass and body composition.
Participants will receive either continuous enteral nutrition for 24 hours a day or intermittent enteral nutrition during the day, consisting of 4 portions each administered over 1 hour between 8 am and 8 pm. The maximum duration of the intervention is 5 days or until participants do not receive exclusive gastric enteral nutrition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous enteral nutrition | No Intervention | Participants will receive the standard of care, continuous enteral nutrition for 24 hours a day. | |
| Intermittent enteral nutrition | Experimental | Participants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent enteral nutrition | Other | Participants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic variability | The primary outcome is the mean glycaemic variability per 24 hours during the intervention, measured with Continuous Glucose Monitoring (CGM), expressed as the Coefficient of Variation (COV). The 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. | From enrollment to the end of the intervention at a maximum of 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic control | Assessed by mean and standard deviation of interstitial glucose concentrations and Mean Amplitude of Glycaemic Excursions (MAGE) (mmol/L) | From enrollment to the end of the intervention at a maximum of 5 days |
| Insulin administred during intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length of stay | ICU length of stay | During index ICU stay, up to 60 days. |
| Days on mechanical ventilation | Days on mechanical ventilation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur RH van Zanten | Contact | +3131843115 | ZantenA@zgv.nl | |
| Imre WK Kouw | Contact | imre.kouw@wur.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelderse Vallei Hospital | Recruiting | Ede | Gelderland | 6716 RP | Netherlands |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Insulin administred during intervention period (IU/day) |
| From enrollment to the end of the intervention at a maximum of 5 days |
| Dysglycemic events during intervention period | Number of hypoglycaemic events, defined as blood glucose level <4.0 mmol/L and number of hyperglycaemic events, defined as blood glucose level >10.0 mmol/L | From enrollment to the end of the intervention at a maximum of 5 days |
| Gastrointestinal tolerance during the intervention period | Gastric residual volumes (mL), minimum, maximum and total volume per 24 hours. | From enrollment to the end of the intervention at a maximum of 5 days. |
| Gastrointestinal tolerance during the intervention period | Incidence of vomiting, diarrhoea, constipation and regurgitation during the intervetion periode | From enrollment to the end of the intervention at a maximum of 5 days |
| Circadian rhythm | Assessed by 24-hour curves of melatonin ( pg/mL) in saliva. | Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU. |
| Circadian rhythm | Assessed by 24-hour curves of cortisol( nmol/L) in saliva. | Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU. |
| Circadian rhythm | Assessed by 24-hour curves of mRNA expression of essential clock genes (BMAL, CLOCK, Cry1 and Per2). | Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU. |
| Body composition | Fat-free mass, fat mass and skeletal muscle mass (kg and %) by bio-electrical impendence analysis. This outcome is only measured in centres with the necessary equipment. | Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU. |
| Muscle size | Cross-sectional area and muscle layer thickness of quadriceps muscle by ultrasonography. This outcome is only measured in centres with the necessary equipment. | Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU. |
| Nutritional intake during intervention period | Total nutritional prescription and delivery per calendar day (energy in kJ/day, protein in g/day, fat in g/day and carbohydrate in g/day and % of total intake) | From enrollment to the end of the intervention at a maximum of 5 days. |
| Non-nutritonal calories administred during intervention period | Non-nutritional calories delivered by propofol, glucose infusion, and citrate, delivery in kJ per calendar day | From enrollment to the end of the intervention at a maximum of 5 days |
| Health-related quality of life | Health-related quality of life measured with the 36-Item Short Form Health Survey (SF-36), 60 days after ICU admission | 60 days after ICU admission |
| Sleep quality | Sleep quality measured with the Pittsburgh Sleep Quality Index (PSQI) | 60 days after ICU admission |
| Glucoregulatory gastrointestinal hormones | GLP-1, C-peptide, insulin, and glucagon concentrations (mmol/L). This outcome is only measured in the coordinating centre. | From 12:00 until 14:00 on the second study day. |
| During index ICU stay, up to 60 days. |
| Deventer Ziekenhuis | Recruiting | Deventer | Overijssel | 7416 SE | Netherlands |
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| Medisch Spectrum Twente | Recruiting | Enschede | Overijssel | 7512KZ | Netherlands |
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| Martini Ziekenhuis | Recruiting | Groningen | Provincie Groningen | 9728NT | Netherlands |
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| Haga Ziekenhuis | Recruiting | The Hague | South Holland | 2545 AA | Netherlands |
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