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This study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20 ventilated ICU patients. The primary endpoint of study is the feasibility to attain the individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after ICU admission. Secondary endpoints include tolerance and efficacy in terms of the amino acid response in blood.
In the present pilot study, the investigators will use a high whey-protein nutrition formula during the first four days of ICU admission. The reason for using a high protein nutrition is that the investigators previously found that an early high protein intake in non-septic non-overfed patients was associated with lower hospital mortality (Weijs PJM et. al., Critical Care 2014,18). Furthermore, during the first days of critical illness tolerance to full enteral nutrition is often diminished. The use of a high protein nutrition will facilitate an early high protein intake.
The whey protein is hydrolysed. Hydrolyzation of protein prevents coagulation and subsequent solidification in the digestive tract and therefore promotes efficient absorption of the protein. Of all nutrition proteins, whey protein has the largest leucin content. Leucin is crucial for muscle protein synthesis. (Meyer RF, et.al.: BMC Gastroenterol 2015, 15), (Marik PE: Ann Intensive Care 2015,5:51)
Our previous observational data also showed that early overfeeding was associated with higher mortality, while an intake of 80-100% of measured energy expenditure at day 4 of ICU admission was associated with lower mortality. (Weijs PJM et. al., Critical Care 2014, 18)
Therefore, the energy target during the first four days will be 90% of the measured Energy Expenditure (EE). To optimize energy intake, the investigators will measure EE by metabolic monitoring (Deltatrac®, Datex, Helsinki, Finland), If metabolic monitoring is not available, the investigators will assess EE from the ventilator derived VCO2 (8.19*VCO2). (Stapel S, et.al., Critical Care 2015,19:370)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresubin Intensive | Adult critically ill non-septic ventilated patients admitted to the intensive care unit with an expected intensive care stay of four days or more. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresubin intensive | Other | Enteral nutrition containing a high protein concentration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients reaching the individualized protein target (≥1.2 g/kg ideal body weight/day) 96 hours after ICU admission | Protein target | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Protein intake 48 hours and 96 hours after start (g/day) | Protein intake | 48 and 96 hours |
| Number of patients with adverse events related to nutrition, as defined by: high gastric retention,abdominal distension, vomiting, diarrhea, need of prokinetics or duodenal tube |
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Inclusion Criteria:
Exclusion Criteria:
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Ventilated critically ill patients in the ICU
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| Name | Affiliation | Role |
|---|---|---|
| Heleen M. Oudemans-van Straaten, MD. Prof. | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU Medical Center | Amsterdam | North Holland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26472544 | Background | Meyer R, Foong RX, Thapar N, Kritas S, Shah N. Systematic review of the impact of feed protein type and degree of hydrolysis on gastric emptying in children. BMC Gastroenterol. 2015 Oct 15;15:137. doi: 10.1186/s12876-015-0369-0. | |
| 26055186 | Background | Marik PE. Feeding critically ill patients the right 'whey': thinking outside of the box. A personal view. Ann Intensive Care. 2015 Dec;5(1):51. doi: 10.1186/s13613-015-0051-2. Epub 2015 May 28. |
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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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Gastro-intestinal tolerance |
| During 96 hours |
| Plama leucine concentration (μmol/L) | Amino acid plasma concentration | 0, 48, and 96 hours |
| Muscle mass (kg) | Measured using bioimpedance analysis | 48 and 96 hours |
| Plasma urea concentration (mmol/l) | Metabolic tolerance | 48 and 96 hours |
| Cumulative protein intake 96 hours after start of the study formula (grams) | Cumulative protein intake | 96 hours |
| Time to protein target (protein intake ≥ 1.2 g/kg/day). | Time to target | Up to 96 hours |
| 25499096 | Background | Weijs PJ, Looijaard WG, Beishuizen A, Girbes AR, Oudemans-van Straaten HM. Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients. Crit Care. 2014 Dec 14;18(6):701. doi: 10.1186/s13054-014-0701-z. |
| 26494245 | Background | Stapel SN, de Grooth HJ, Alimohamad H, Elbers PW, Girbes AR, Weijs PJ, Oudemans-van Straaten HM. Ventilator-derived carbon dioxide production to assess energy expenditure in critically ill patients: proof of concept. Crit Care. 2015 Oct 22;19:370. doi: 10.1186/s13054-015-1087-2. |