As meeting protein requirements seems to be very important in critically ill patients, the primary objective of the current study is to investigate protein intake with the new tube feed.
ID
Source
Brief title
Condition
- Other condition
- General system disorders NEC
- Appetite and general nutritional disorders
Synonym
Health condition
- 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.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is protein intake (g/kg body
weight/day)
Secondary outcome
To evaluate gastro intestinal tolerance, energy intake and safety of the test
product compared to the control product.
Background summary
Circumstantial evidence collected in prospective observational trials indicates
a higher protein intake up to about 1.5 g/kg body weight is associated with
lower mortality compared to lower protein intake. (Allingstrup 2012, Weijs
2011).
Study objective
As meeting protein requirements seems to be very important in critically ill
patients, the primary objective of the current study is to investigate protein
intake with the new tube feed.
Study design
This is a randomized, controlled, double-blind, parallel-group, multi-centre,
multi-country study.
Intervention
Providing a tube feed to the subject other than standard care for a maximum
duration of 28 days.
Collecting a maximum of 70 ml. blood.
Follow-up call (if applicable)
Study burden and risks
The new tube feed is developed for ICU patients who need very high amounts of
protein. Patients might benefit from the high amount of protein in the test
product. Participation of patients in the study may lead to introduction of the
new tube feed to the market. No problems related to the use of the study
product are expected. Because of the high protein amounts in the test product,
kidney function will be monitored. In general, administration of tube feed may
lead to constipation or diarrhoea. As a consequence of the blood drawing,
bruising or swelling at the place of the needle stick can occur.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51412.075.14 |