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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR2181
• Date of registration: 26/01/2010
• Primary sponsor: Danone Research B.V.
• Public title: The effect of a new tube feed on clinical outcome in critically ill patients.
• Scientific title: The effect of a new tube feed on clinical outcome in critically ill patients. - METAPLUS
• Date of first enrolment: 25/1/2010
• Target sample size: 300
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2181
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Saskia Zaaijer

• Name: Zandrie Hofman

Key inclusion & exclusion 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: 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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Critically ill, First Aid

Intervention(s)

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.

Primary Outcome(s)

To determine the effect of the test product compared to the control product on incidence of nosocomial infections.

Secondary Outcome(s)

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.

Secondary ID(s)

Tub.2.C/A

Source(s) of Monetary Support

Danone Research B.V.