Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient

Conditions
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Critically Ill

Intervention / Treatment
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* Other: Specific Enteral Nutrition
* Other: Standard Enteral Nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Specific Enteral formulation<br> | Other: Specific Enteral Nutrition<br>* 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).<br>|
| Placebo Comparator: Standard enteral formulation<br> | Other: Standard Enteral Nutrition<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU) | Patients will receive treatment for 10 days maximum | from EN start until end of treatment or ICU discharge (whatever comes first) | 
| Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU) | Patients will receive treatment for 10 days maximum | from EN start until end of treatment or ICU discharge (whatever comes firts) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of diarrhea | 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 | up to 10 days | 
| Presence/absence of other abdominal symptoms | If present: description of abdominal distension, pain, absence of bowel sounds | up to 10 days | 
| 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 | 
| Need to use any drug interfering with the passage of nutrition |  | up to 10 days | 
| Visual analogue scale for abdominal discomfort | Assessed in non-comatose patients | up to 10 days | 
| Health Economic burden of Diarrhea during EN administration at ICU | 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.) | up to 10 days | 
| For blood glucose control | 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 | up to 10 days | 
| Time to reach the full caloric goal | 25 Kcal/kg/day or as determined for each patient with indirect calorimetry | up to 10 days | 
| Accumulated daily caloric deficit during 72 hs after start of the study | Percentage of cumulative calories delivered vs. prescribed during hospitalization in ICU and accumulated deficit during ICU stay/day (it should be the same) | up to 10 days | 
| Need for parenteral nutrition supplementation during ICU stay | yes/no, economic impact | up to 10 days | 
| Nutritional assessment | serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first) | up to 10 days | 
| 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 | 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 | up to 10 days | 
| Determination of diarrhea pathogenicity | Infections, fecal cultures for pathogens assessed at diarrhea episodes | up to 10 days | 
| Safety evaluation (blood sampling) | 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 | up to 10 days | 
| AEs (adverse events) / SAEs (serious adverse events) | AE and SAE reporting from study start until 28 days after randomization | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral nutrition, critically ill patients