Gastrointestinal tolerance of an upgraded peptide feed in ICU patients

Gastrointestinal Tolerance in ICU patients after administration of an Energy and Protein enriched Peptide formula as compared to an isocaloric standard tube feed

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28333

Enrollment

Registered

2016-10-14

Start date

2016-10-24

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal tolerance in ICU patients

Interventions

Duration of intervention: 14 days Intervention group: Peptide based tube feed Control group: Isocaloric commercially available tube feed

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Gastrointestinal tolerance	—

Secondary

Measure	Time frame
Clinical outcomes: ICU stay, hospital stay, ventilator free days, mortality, SOFA (sub)score(s) Safety: (S)AE’s and laboratory blood parameters	—

Contacts

Public ContactGerben Hofman

Gerben.Hofman@Nutricia.comT: +31 (0)30 2095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)