No registrations found.
ID
Source
Brief title
Health condition
Catabolic state induced by severe diseases
Sponsors and support
Uppsalalaan 12,
3584 CT Utrecht - The Netherlands
Intervention
Outcome measures
Primary outcome
protein intake (g/kg BW/day)
Secondary outcome
gastro intestinal tolerance, energy intake and safety
Background summary
pending
Study objective
It is hypothesized that the outcome of the outcome parameters will be superior for the test product compared to the control product:
No difference for the test product compared to the control product is anticipated for the outcome parameter Gastrointestinal tolerance and safety.
Study design
Time points of the outcome; for example: V0 (screening); Day 1 – Day 28, FU call day 42.
Intervention
Duration of intervention: 28 days
Intervention group: High protein tube feed
Control group: Isocaloric control tube feed
PO box. 80141
Utrecht 3508CT
The Netherlands
T: +31 (0)30 2095000
Gerben.Hofman@Nutricia.com
PO box. 80141
Utrecht 3508CT
The Netherlands
T: +31 (0)30 2095000
Gerben.Hofman@Nutricia.com
Inclusion criteria
- 18 years and over
- Male and female
- Patient: ICU stay and indication for tube feed via nasogastric tube
- 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 totalling 122 centimetres 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 |
|---|---|
| NTR-new | NL5536 |
| NTR-old | NTR5654 |
| Other | : NTS.2.C/A |