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…
ID
Bron
Verkorte titel
Aandoening
Catabolic state induced by severe diseases
Ondersteuning
Uppsalalaan 12,
3584 CT Utrecht - The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
protein intake (g/kg BW/day)
Achtergrond van het onderzoek
pending
Doel van het onderzoek
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.
Onderzoeksopzet
Time points of the outcome; for example: V0 (screening); Day 1 – Day 28, FU call day 42.
Onderzoeksproduct en/of interventie
Duration of intervention: 28 days
Intervention group: High protein tube feed
Control group: Isocaloric control tube feed
Publiek
PO box. 80141
Utrecht 3508CT
The Netherlands
T: +31 (0)30 2095000
Gerben.Hofman@Nutricia.com
Wetenschappelijk
PO box. 80141
Utrecht 3508CT
The Netherlands
T: +31 (0)30 2095000
Gerben.Hofman@Nutricia.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years and over
- Male and female
- Patient: ICU stay and indication for tube feed via nasogastric tube
- BMI > 25.0 kg/m2
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5536 |
| NTR-old | NTR5654 |
| Ander register | : NTS.2.C/A |