Critically ill patients being treated in an Intensive Care Unit (male and female).
Conditions
Interventions
Duration of intervention: 28 Days (maximum).
1. Intervention group: New tube feed
2. Control group: Isocaloric standard tube feed with the same amount of protein.
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age => 18 years; 2. Being mechanically ventilated; 3. Expected to be mechanically ventilated for more than 72 hours after the start of the administration of the study product; 4. Start of study product administration within 48 hours after ICU admission; 5. Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition according to protocol recommendations; 6. Written informed consent of subject or written informed consent of legal Representative.
Exclusion criteria
Exclusion criteria: 1. Requiring other specific enteral nutrition for medical reason; 2. Having any contra-indication to receive enteral nutrition such as severe or refractory shock, presence of partial or complete mechanical bowel obstruction, or intestinal ischemia or infarction; 3. Pregnant female; 4. BMI > 40.0 kg/m2; 5. Receiving supplements containing specific amino acids, anti-oxidants, fatty acids during two weeks before start study product on doctors’ prescription; 6. History of allergy or intolerance to the study product components (test or control product); 7. SOFA score from admission to the ICU until 24 hours after admission or until randomisation in case of randomisation before 24 hours after admission > 12; 8. Current or planned treatment with preventive selective decontamination of the digestive tract (SDD, prophylactic administration of non-absorbable antibiotics by mouth or through a nasogastric tube) or selective oral decontamination (SOD, prophylactic topical oral application of antibiotics); 9. GI tract/short bowel syndrome - defined as entire length of small bowel totalling 122 centimetres or less; 10. Participating in another intervention clinical trial involving investigational products concomitantly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of the test product compared to the control product on incidence of nosocomial infections. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the effect of the test product compared to the control product on Sepsis-related Organ Failure Assessment (SOFA) score, duration of ventilation, Intensive Care Unit (ICU) and hospital stay and mortality; 2. To evaluate safety and tolerance of the test product compared to the control product. | — |
Contacts
Public ContactSaskia Zaaijer
Bosrandweg 20
Outcome results
None listed