search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Protein intake, tolerance and safety of a new high protein tube feed in critically ill overweight ICU patients as compared to standard tube feed.


- candidate number23702
- NTR NumberNTR5654
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2016
- Secondary IDsNTS.2.C/A 
- Public TitleProtein intake, tolerance and safety of a new high protein tube feed in critically ill overweight ICU patients as compared to standard tube feed.
- Scientific TitleProtein 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.
- ACRONYMPROTILL
- hypothesisIt 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.
- Healt Condition(s) or Problem(s) studiedNutrition
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-feb-2016
- planned closingdate15-feb-2017
- Target number of participants44
- InterventionsDuration of intervention: 28 days
Intervention group: High protein tube feed
Control group: Isocaloric control tube feed
- Primary outcomeprotein intake (g/kg BW/day)
- Secondary outcomegastro intestinal tolerance, energy intake and safety
- TimepointsTime points of the outcome; for example: V0 (screening); Day 1 – Day 28, FU call day 42.
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Gerben Hofman
- CONTACT for SCIENTIFIC QUERIESPhD Janneke van Wijngaarden
- Sponsor/Initiator Nutricia Netherlands
- Funding
(Source(s) of Monetary or Material Support)
None
- Publicationspending
- Brief summarypending
- Main changes (audit trail)
- RECORD2-feb-2016 - 23-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl