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The effect of a new tube feed on clinical outcome in critically ill patients.


- candidate number7686
- NTR NumberNTR2181
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2010
- Secondary IDsTub.2.C/A  Danone Research
- Public TitleThe effect of a new tube feed on clinical outcome in critically ill patients.
- Scientific TitleThe effect of a new tube feed on clinical outcome in critically ill patients.
- ACRONYMMETAPLUS
- hypothesisThe new tube feed will decrease the incidence of nosocomial infections in critically ill patients compared to an isocaloric control product with similar amounts of protein.
- Healt Condition(s) or Problem(s) studiedCritically ill, First Aid
- Inclusion criteria1. 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 criteria1. 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 doctorsí 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-jan-2010
- planned closingdate25-sep-2011
- Target number of participants300
- InterventionsDuration of intervention: 28 Days (maximum).
1. Intervention group: New tube feed;
2. Control group: Isocaloric standard tube feed with the same amount of protein.
- Primary outcomeTo determine the effect of the test product compared to the control product on incidence of nosocomial infections.
- Secondary outcome1. 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.
- TimepointsTime points of the outcome:
1. Measurements of nosocomial infections until discharge from ICU;
2. Measurement of product administration and risk factors until discharge from ICU;
3. SOFA score: screening, Day1-10 and Day 28;
4. Safety: Daily measurements of (S) AEs and Blood safety measurements at Baseline, Day 4 and 8;
5. Day 28 and 6 month mortality;
6. Measurement of gastro-intestinal tolerance until discharge from ICU.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Saskia Zaaijer
- CONTACT for SCIENTIFIC QUERIES Zandrie Hofman
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryIn this trial the effect of the test product will be compared to the control product on the incidence of nosocomial infections in critically ill patients being admitted to the Intensive Care and mechanically ventilated. The study product will be administered for maximally 28 Days.
- Main changes (audit trail)
- RECORD26-jan-2010 - 7-feb-2010


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