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Protein intake, gastro-Intestinal tolerance and safety after administration of a new high protein tube feed in critically ill overweight ICU patients as compared to an isocaloric standard tube feed.

Phase 2
Conditions
-Tegen gaan van de katabole status welke geïnduceerd is door ernstige ziekte - het verbeteren van de wondgenezing, ondersteuning van het immuunsysteem en behoud van vet vrije massa bij patiënten op de Intensive Care.
catabolic state induced by severe diseases - lack of adequate nutrition
due to severe diseases
especially protein
10018073
10003018
Registration Number
NL-OMON42168
Lead Sponsor
utricia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
22
Inclusion Criteria

1. Age * 18 years.
2. ICU stay and indication for tube feed via nasogastric tube.
3. Expected to require study product for at least 5 days on the ICU
4. BMI >= 25.0 kg/m2

Exclusion Criteria

- Requiring other specific tube feed for medical reason.
- Having any contra-indication to receive tube feed such as severe shock, presence of partial or complete mechanical bowel obstruction, or intestinal ischemia or infarction.
- Abnormalities in GI tract which may impact GI function, such as short bowel syndrome - defined as entire length of small bowel totaling 122 centimeters or less-, Ulcerative Colitis or Crohn*s disease or any form of enterostomy.
- GI tract, abdominal or bariatric surgery within 72 hours before start intake study product or expected in the next 5 days after start study product intake.
- History of chronic pancreatitis or acute pancreatitis
- Expected to need parenteral feeding.
- Expected to need protein supplementation other than study product
- SOFA score >12 from admission to the ICU until 24 hours after admission or until randomisation in case of randomisation before 24 hours after admission

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome parameter in this study is protein intake (g/kg body<br /><br>weight/day) </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>To evaluate gastro intestinal tolerance, energy intake and safety of the test<br /><br>product compared to the control product.</p><br>
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