The primary objective of the CONVEnIENT trial is to investigate the effect of daytime intermittent enteral tube feeding, compared to a standard continuous tube feeding pattern (24-hour/day), on glycaemic control, gastrointestinal function, circadian…
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
- Glucose metabolism disorders (incl diabetes mellitus)
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
1.Glycaemic control (assessed by CGM and blood samples):
- Mean interstitial glucose concentrations per day (mmol/L)
- SD of mean interstitial glucose concentrations per 24 h
- Mean insulin dose (IU/day)
- Mean Amplitude of Glucose Excursions (MAGE)
- Mean plasma insulin concentrations (*µU/mL/24h)
- HbA1c at admission (%)
- Hypoglycaemic events per day (blood glucose level below 4.0 mmol/L)
- Hyperglycaemic events per day (blood glucose level above 10.0 mmol/L)
2. Gastrointestinal tolerance/function (assessed as part of clinical practice,
extracted from patient records):
- Gastric residual volumes (mL), total per 24h and largest volume per 24h
(assessed as part of clinical practice)
- Incidence of vomiting, diarrhoea, constipation, and regurgitation per 24 h
3. Marker of inflammation (extracted from patient records)
- CRP at admission ((mg/L)
4. Sleep quality and circadian rhythm (assessed from blood and saliva samples
at the start and end of the intervention and extracted from patient records):
- Melatonin and cortisol levels obtained at 6 time points in saliva (06:00,
10:00, 14:00, 18:00, 22:00, 02:00)
- mRNA expression of essential clock genes (BMAL, CLOCK, Cry1 and, Per2)
obtained at 6 time points in blood (06:00, 10:00, 14:00, 18:00, 22:00, 02:00)
- Core body temperature per day (°C, mean, highest and lowest value/24h)
- Mean, highest and lowest Richmond Agitation Sedation Scale (RASS) score per
24 h
- Glasgow Coma Scale (GCS) score per 24 h
- Delerium Observation Screening (DOS) scale per calendar day
- Confusion Assessment Method for the ICU (CAM-ICU) scores per calendar day
- Sleep quality measured with the Pittsburgh Sleep Quality Index (PSQI) at T=3
5. Muscle mass and body composition (assessed by BIA and muscle ultrasound at
the start and end of intervention), only in centers with available equipment
for these measurements:
- Cross-sectional area and muscle layer thickness of quadriceps muscle by
ultrasonography
- Fat-free mass (FFM), fat mass (FM), skeletal muscle mass (SMM), intracellular
water (ICW), extracellular water (ECW), body fat percentage (BF%), total body
water (TBW), ECW/TBW-ratio by bio-electrical impendence analysis
6. Nutrition intake (extracted from patient records):
- Total nutritional intake per day (energy in kJ/24h, protein in g/24 h, fat in
g/24 h and carbohydrate in g/24h and % of total intake)
7. Quality of life
- Health-related quality of life measured with SF-36
Background summary
Optimal timing of nutritional therapy has the potential to reduce metabolic
complications in intensive care unit (ICU) patients, including improving
glycemic control, restoring circadian rhythm and reducing loss of muscle mass
during critical illness. This could potentially reduce long-term consequences
such as post intensive care syndrome. This effect is expected because
intermittent tube feeding, unlike continuous feeding, improves insulin
sensitivity, increases the rate of muscle protein synthesis (MPS), activates
fasting-induced autophagy and ketogenesis, and maintains circadian rhythm in
studies in healthy humans and animals. However, studies in critically ill
humans show conflicting results regarding these metabolic outcomes, and
therefore, in the current study, we want to investigate these outcomes
simultaneously in intensive care patients. If the results show that
intermittent tube feeding during the day is better for the metabolic outcomes
studied compared to continuous tube feeding, international guidelines for
nutrition in the ICU can potentially be improved.
Study objective
The primary objective of the CONVEnIENT trial is to investigate the effect of
daytime intermittent enteral tube feeding, compared to a standard continuous
tube feeding pattern (24-hour/day), on glycaemic control, gastrointestinal
function, circadian rhythms, and muscle mass in critically ill patients.
Study design
Multicentre, randomised controlled trial, with two parallel groups.
Intervention
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.
Study burden and risks
This study will include invasively mechanically ventilated patients admitted to
the ICU. This is a vulnerable patient group that, due to the nature of their
condition, will not be able to give informed consent before the start of the
study. However, alternative models or patients are not able to answer our
research question, as it is specific to this patient group. Critical illness
(for which mechanical ventilation is necessary for an undetermined period) is a
severe, life-threatening disease with unique and detrimental metabolic
derangements. Previous work on intermittent nutrition administration and
metabolic outcomes in healthy or less severe disease conditions cannot simply
be extrapolated to ICU patients. The study's findings will inform clinical
practice to optimise nutritional care for critically ill patients. The proposed
study is believed to pose no significant ethical issues. Screening eligible
patients involves accessing medical records to assess in- and exclusion
criteria, and, with appropriate measures in place to preserve privacy and
confidentiality, it is a negligible-risk procedure. The care provided to
patients will be unaffected by participation in the study. All measurements
performed during the study are non-invasive (glycaemic control assessed by
continuous glucose monitoring, circadian rhythms assessed by clock genes in
blood samples (in total 44 mL), melatonin, and cortisol in saliva samples and
body composition and muscle mass by BIA and ultrasound), or part of standard
clinical care (gastrointestinal function assessed by gastric residual
volumes).
Willy Brandtlaan 10
Ede 6716RP
NL
Willy Brandtlaan 10
Ede 6716RP
NL
Listed location countries
Age
Inclusion criteria
1. Age >=18 years
2. Receiving or eligible to receive exclusively gastric tube feeding
3. Expected ICU stay >=48 hours
4. Receiving invasive mechanical ventilation upon initiation of the study
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88158.091.24 |