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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific Enteral formulation | Active Comparator |
| |
| Standard enteral formulation | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific Enteral Nutrition | Other | 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). |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of diarrhea |
| up to 10 days |
| Presence/absence of other abdominal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Jakob, Professor | Bern University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care Medicine. Bern University Hospital | Bern | Canton of Bern | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28599662 | Derived | Jakob SM, Butikofer L, Berger D, Coslovsky M, Takala J. A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Crit Care. 2017 Jun 10;21(1):140. doi: 10.1186/s13054-017-1730-1. |
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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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| Standard Enteral Nutrition | Other | 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). |
|
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 |
| up to 10 days |
| For blood glucose control |
| 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 |