No registrations found.
ID
Source
Brief title
Health condition
Gastrointestinal tolerance in ICU patients
Sponsors and support
Uppsalalaan 12,
3584 CT Utrecht - The Netherlands
Intervention
Outcome measures
Primary outcome
Gastrointestinal tolerance
Secondary outcome
Clinical outcomes: ICU stay, hospital stay, ventilator free days, mortality, SOFA (sub)score(s)
Safety: (S)AE’s and laboratory blood parameters
Background summary
pending
Study design
Screening
Intervention: Day 1 – Day 14
Follow-up: Day 28
Intervention
Duration of intervention: 14 days
Intervention group: Peptide based tube feed
Control group: Isocaloric commercially available 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
Main 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 criteria
Main 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
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 | NL5798 |
| NTR-old | NTR6073 |
| Other | REC Reference number: 16/LO/1486 : Protocol number: MPR16TA06066 |