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Gastrointestinal tolerance of an upgraded peptide feed in ICU patients


- candidate number25409
- NTR NumberNTR6073
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2016
- Secondary IDsProtocol number: MPR16TA06066 REC Reference number: 16/LO/1486
- Public TitleGastrointestinal tolerance of an upgraded peptide feed in ICU patients
- Scientific TitleGastrointestinal Tolerance in ICU patients after administration of an Energy and Protein enriched Peptide formula as compared to an isocaloric standard tube feed
- ACRONYMSTEPP
- hypothesis
- Healt Condition(s) or Problem(s) studiedIntensive Care (IC) patients, Gastrointestinal disease
- Inclusion criteriaMain inclusion criteria:
• Age >=18 years;
• Admitted to the ICU;
• Expected to be on tube feeding for >=5 days;
• Start of tube feeding within 48 hours after ICU admission
- Exclusion criteriaMain exclusion criteria:
• Requiring other tube feed for medical reason;
• Not suitable for tube feeding;
• Allergy or intolerance for cow’s milk protein, soy or pea protein;
• Gastrointestinal disease such as Crohn’s or Ulcerative Colitis or other conditions affecting absorption such as short bowel syndrome;
• Pancreatic, liver or renal failure;
• Sequential organ failure assessment (SOFA) score >12 within first 24 hours after admission;
• Being pregnant;
• Participating in another clinical intervention trial
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-okt-2016
- planned closingdate31-jan-2018
- Target number of participants30
- InterventionsDuration of intervention: 14 days
Intervention group: Peptide based tube feed
Control group: Isocaloric commercially available tube feed
- Primary outcomeGastrointestinal tolerance
- Secondary outcomeClinical outcomes: ICU stay, hospital stay, ventilator free days, mortality, SOFA (sub)score(s)
Safety: (S)AE’s and laboratory blood parameters
- TimepointsScreening
Intervention: Day 1 – Day 14
Follow-up: Day 28
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Gerben Hofman
- CONTACT for SCIENTIFIC QUERIESPhD. Janneke Wilde, de
- Sponsor/Initiator Nutricia Netherlands
- Funding
(Source(s) of Monetary or Material Support)
None
- Publicationspending
- Brief summarypending
- Main changes (audit trail)
- RECORD14-okt-2016 - 25-nov-2016


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