Critically Ill
Conditions
Keywords
Enteral nutrition, critically ill patients
Brief summary
Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient. This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.
Interventions
OTHERSpecific Enteral Nutrition
Patients will receive a Specific EN. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).
Patients will receive an equivalent volume and caloric intake of standard formulation. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female older than 18 years of age * All ICU patients * Expected ICU stay superior or equal to 5 days * Anticipated to receive tube feeding for at least 3 days * Informed consent obtained from patient or close relative
Exclusion criteria
* Contraindication to enteral nutrition or to the placement of an enteral feeding tube * On enteral nutrition with superior or equal to 75% of caloric goal administered * Restriction in full intestinal support including protein administration * Parenteral nutrition of any kind unless due to enteral nutrition intolerance * History of allergy or intolerance to the study product components (test or control product) * Currently under therapeutic limitations. Non functional GI tract * Unwilling or unable to comply with study treatments * Currently participating or having participated in another clinical, interventional trial during the last month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU) | from EN start until end of treatment or ICU discharge (whatever comes first) | Patients will receive treatment for 10 days maximum |
| Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU) | from EN start until end of treatment or ICU discharge (whatever comes firts) | Patients will receive treatment for 10 days maximum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of diarrhea | up to 10 days | * Number of patients that experienced diarrhea during ICU stay * Interruption of EN due to diarrhea * Presence/absence of electrolyte and acid-base disturbances secondary to diarrhea |
| Presence/absence of other abdominal symptoms | up to 10 days | If present: description of abdominal distension, pain, absence of bowel sounds |
| Changes in intra-abdominal pressure | up to 10 days | — |
| Incidence of nausea, vomiting and regurgitation | up to 10 days | — |
| Gastric residual volumes (>500 ml) | up to 10 days | — |
| Health Economic burden of Diarrhea during EN administration at ICU | up to 10 days | * Nurse workload for the management of patients with diarrhea during the EN feeding period in ICU * Total cost of diarrhea evaluated for each patient who experienced diarrhea (medications, cleaning material, blankets, etc.) |
| For blood glucose control | up to 10 days | * Number of events outside the 4.5 to 10 mmol/l glycaemic range * Need for insulin unit administration during exclusive enteral nutrition * Need for glucose administration during exclusive enteral nutrition |
| Time to reach the full caloric goal | up to 10 days | 25 Kcal/kg/day or as determined for each patient with indirect calorimetry |
| Need to use any drug interfering with the passage of nutrition | up to 10 days | — |
| Need for parenteral nutrition supplementation during ICU stay | up to 10 days | yes/no, economic impact |
| Nutritional assessment | up to 10 days | serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first) |
| Incidence of secondary infections | up to 10 days | — |
| ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay) | up to 28 days | — |
| Microbiota profiling | up to 10 days | Comprehensive intestinal microbiota profiling by sequencing-based approaches in stool samples collected right before initiation of EN, 3 days after EN start, at treatment end or at ICU discharge (whatever comes first), and at diarrhea episodes |
| Determination of diarrhea pathogenicity | up to 10 days | Infections, fecal cultures for pathogens assessed at diarrhea episodes |
| Safety evaluation (blood sampling) | up to 10 days | End-point of safety evaluation at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first), will include: blood cell analysis, hemoglobin, hepatic enzymes and creatinine |
| AEs (adverse events) / SAEs (serious adverse events) | up to 28 days | AE and SAE reporting from study start until 28 days after randomization |
| Accumulated daily caloric deficit during 72 hs after start of the study | up to 10 days | Percentage of cumulative calories delivered vs. prescribed during hospitalization in ICU and accumulated deficit during ICU stay/day (it should be the same) |
| Visual analogue scale for abdominal discomfort | up to 10 days | Assessed in non-comatose patients |
Countries
Switzerland
Outcome results
None listed